Other products from "SHOCKWAVE MEDICAL, INC."
No Primary DI Version or Model Catalog Number Device Description Product Code Product Code Name Device Class Brand Name
1 00195451000300 825DP IVLCC The Shockwave Medical Intravascular Lithotripsy (IVL) Connector Cable is a remot The Shockwave Medical Intravascular Lithotripsy (IVL) Connector Cable is a remote actuator which connects the IVL Generator to the IVL Catheter and is used to activate lithotripsy energy within the IVL balloon catheter. PPN,QMG Percutaneous Catheter, Ultrasound,Shockwave Intravascular Lithotripsy System 2 Shockwave Intravascular Lithotripsy (IVL) Connector Cable
2 00195451000119 4.0 x 12mm C2IVL4012 The Shockwave C2 Catheter is a proprietary lithotripsy device delivered through The Shockwave C2 Catheter is a proprietary lithotripsy device delivered through the coronary arterial system of the heart to the site of an otherwise difficult to treat calcified stenosis, including calcified stenosis that are anticipated to exhibit resistance to full balloon dilation or subsequent uniform coronary stent expansion. The IVL Catheter contains integrated lithotripsy emitters for the localized delivery of acoustic pressure pulse therapy. The lithotripsy technology generates acoustic pressure pulses within the target treatment site, disrupting calcium within the lesion allowing subsequent dilatation of a coronary artery stenosis using low balloon pressure. The system consists of the IVL Catheter, IVL Connector Cable and IVL Generator. The Shockwave C2 Catheter is available in four (4) sizes: 2.5x12mm, 3.0x12mm, 3.5x12mm, and 4.0x12mm. The Shockwave C2 is compatible with a 6F guiding catheter and extensions, has a working length of 138cm, and shaft depth markers at the proximal end. The catheter is coated with hydrophilic coating to 22.75 cm from the distal tip to reduce friction during device delivery. QMG Shockwave Intravascular Lithotripsy System 3 Shockwave IVL System with the Shockwave C2 Coronary IVL Catheter
3 00195451000102 3.5 x 12mm C2IVL3512 The Shockwave C2 Catheter is a proprietary lithotripsy device delivered through The Shockwave C2 Catheter is a proprietary lithotripsy device delivered through the coronary arterial system of the heart to the site of an otherwise difficult to treat calcified stenosis, including calcified stenosis that are anticipated to exhibit resistance to full balloon dilation or subsequent uniform coronary stent expansion. The IVL Catheter contains integrated lithotripsy emitters for the localized delivery of acoustic pressure pulse therapy. The lithotripsy technology generates acoustic pressure pulses within the target treatment site, disrupting calcium within the lesion allowing subsequent dilatation of a coronary artery stenosis using low balloon pressure. The system consists of the IVL Catheter, IVL Connector Cable and IVL Generator. The Shockwave C2 Catheter is available in four (4) sizes: 2.5x12mm, 3.0x12mm, 3.5x12mm, and 4.0x12mm. The Shockwave C2 is compatible with a 6F guiding catheter and extensions, has a working length of 138cm, and shaft depth markers at the proximal end. The catheter is coated with hydrophilic coating to 22.75 cm from the distal tip to reduce friction during device delivery. QMG Shockwave Intravascular Lithotripsy System 3 Shockwave IVL System with the Shockwave C2 Coronary IVL Catheter
4 00195451000096 3.0 x 12mm C2IVL3012 The Shockwave C2 Catheter is a proprietary lithotripsy device delivered through The Shockwave C2 Catheter is a proprietary lithotripsy device delivered through the coronary arterial system of the heart to the site of an otherwise difficult to treat calcified stenosis, including calcified stenosis that are anticipated to exhibit resistance to full balloon dilation or subsequent uniform coronary stent expansion. The IVL Catheter contains integrated lithotripsy emitters for the localized delivery of acoustic pressure pulse therapy. The lithotripsy technology generates acoustic pressure pulses within the target treatment site, disrupting calcium within the lesion allowing subsequent dilatation of a coronary artery stenosis using low balloon pressure. The system consists of the IVL Catheter, IVL Connector Cable and IVL Generator. The Shockwave C2 Catheter is available in four (4) sizes: 2.5x12mm, 3.0x12mm, 3.5x12mm, and 4.0x12mm. The Shockwave C2 is compatible with a 6F guiding catheter and extensions, has a working length of 138cm, and shaft depth markers at the proximal end. The catheter is coated with hydrophilic coating to 22.75 cm from the distal tip to reduce friction during device delivery. QMG Shockwave Intravascular Lithotripsy System 3 Shockwave IVL System with the Shockwave C2 Coronary IVL Catheter
5 00195451000089 2.5 x 12mm C2IVL2512 The Shockwave C2 Catheter is a proprietary lithotripsy device delivered through The Shockwave C2 Catheter is a proprietary lithotripsy device delivered through the coronary arterial system of the heart to the site of an otherwise difficult to treat calcified stenosis, including calcified stenosis that are anticipated to exhibit resistance to full balloon dilation or subsequent uniform coronary stent expansion. The IVL Catheter contains integrated lithotripsy emitters for the localized delivery of acoustic pressure pulse therapy. The lithotripsy technology generates acoustic pressure pulses within the target treatment site, disrupting calcium within the lesion allowing subsequent dilatation of a coronary artery stenosis using low balloon pressure. The system consists of the IVL Catheter, IVL Connector Cable and IVL Generator. The Shockwave C2 Catheter is available in four (4) sizes: 2.5x12mm, 3.0x12mm, 3.5x12mm, and 4.0x12mm. The Shockwave C2 is compatible with a 6F guiding catheter and extensions, has a working length of 138cm, and shaft depth markers at the proximal end. The catheter is coated with hydrophilic coating to 22.75 cm from the distal tip to reduce friction during device delivery. QMG Shockwave Intravascular Lithotripsy System 3 Shockwave IVL System with the Shockwave C2 Coronary IVL Catheter
6 M732LPBC5060DX1 M732LPBC5060DX1 M732LPBC5060DX1 The Shockwave Medical Lithoplasty® Catheter is a proprietary balloon catheter fo The Shockwave Medical Lithoplasty® Catheter is a proprietary balloon catheter for lithotripsy-enhanced balloon dilatation of otherwise difficult to treat calcified stenosis of the peripheral vasculature. PPN Percutaneous Catheter, Ultrasound 2 Lithoplasty®
7 M732LPBC4060DX1 M732LPBC4060DX1 M732LPBC4060DX1 The Shockwave Medical Lithoplasty® Catheter is a proprietary balloon catheter fo The Shockwave Medical Lithoplasty® Catheter is a proprietary balloon catheter for lithotripsy-enhanced balloon dilatation of otherwise difficult to treat calcified stenosis of the peripheral vasculature. PPN Percutaneous Catheter, Ultrasound 2 Lithoplasty®
8 M732LPBC3560DX1 M732LPBC3560DX1 M732LPBC3560DX1 The Shockwave Medical Lithoplasty® Catheter is a proprietary balloon catheter fo The Shockwave Medical Lithoplasty® Catheter is a proprietary balloon catheter for lithotripsy-enhanced balloon dilatation of otherwise difficult to treat calcified stenosis of the peripheral vasculature. PPN Percutaneous Catheter, Ultrasound 2 Lithoplasty®
9 M732LPBC6060DX1 M732LPBC6060DX1 M732LPBC6060DX1 The Shockwave Medical Lithoplasty® Catheter is a proprietary balloon catheter fo The Shockwave Medical Lithoplasty® Catheter is a proprietary balloon catheter for lithotripsy-enhanced balloon dilation of otherwise difficult to treat calcified stenosis of the peripheral vasculature. PPN Percutaneous Catheter, Ultrasound 2 Lithoplasty®
10 M732LPBC4560DX1 M732LPBC4560DX1 M732LPBC4560DX1 The Shockwave Medical Lithoplasty® Catheter is a proprietary balloon catheter fo The Shockwave Medical Lithoplasty® Catheter is a proprietary balloon catheter for lithotripsy-enhanced balloon dilatation of otherwise difficult to treat calcified stenosis of the peripheral vasculature. PPN Percutaneous Catheter, Ultrasound 2 Lithoplasty®
11 M732LPBC7060DX1 M732LPBC7060DX1 M732LPBC7060DX1 The Shockwave Medical Lithoplasty® Catheter is a proprietary balloon catheter fo The Shockwave Medical Lithoplasty® Catheter is a proprietary balloon catheter for lithotripsy-enhanced balloon dilation of otherwise difficult to treat calcified stenosis of the peripheral vasculature. PPN Percutaneous Catheter, Ultrasound 2 Lithoplasty®
12 M732LPBC6560DX1 M732LPBC6560DX1 M732LPBC6560DX1 The Shockwave Medical Lithoplasty® Catheter is a proprietary balloon catheter fo The Shockwave Medical Lithoplasty® Catheter is a proprietary balloon catheter for lithotripsy-enhanced balloon dilation of otherwise difficult to treat calcified stenosis of the peripheral vasculature. PPN Percutaneous Catheter, Ultrasound 2 Lithoplasty®
13 M732LPBC5560DX1 M732LPBC5560DX1 M732LPBC5560DX1 The Shockwave Medical Lithoplasty® Catheter is a proprietary balloon catheter fo The Shockwave Medical Lithoplasty® Catheter is a proprietary balloon catheter for lithotripsy-enhanced balloon dilation of otherwise difficult to treat calcified stenosis of the peripheral vasculature. PPN Percutaneous Catheter, Ultrasound 2 Lithoplasty®
14 M732LGCC825DX1 M732LGCC825DX1 M732LGCC825DX1 The Shockwave Medical Inc. Lithoplasty® Generator provides power and exchanges d The Shockwave Medical Inc. Lithoplasty® Generator provides power and exchanges data via a Connector Cable to the Lithoplasty® Catheters, which deliver localized lithotripsy-enhanced balloon dilatation of calcified stenotic peripheral arteries. PPN Percutaneous Catheter, Ultrasound 2 Lithoplasty®
15 M732LCC825D1 M732LCC825D1 M732LCC825D1 The Shockwave Medical Lithoplasty® Connector Cable is a remote actuator which co The Shockwave Medical Lithoplasty® Connector Cable is a remote actuator which connects the Lithoplasty® Generator to the Lithoplasty® Catheter and is used to activate lithotripsy energy within the balloon. PPN,QMG Percutaneous Catheter, Ultrasound,Shockwave Intravascular Lithotripsy System 2 Lithoplasty®
16 M732IVLCC0 825DP IVLCC The Shockwave Medical Intravascular Lithotripsy (IVL) Connector Cable is a remot The Shockwave Medical Intravascular Lithotripsy (IVL) Connector Cable is a remote actuator which connects the IVL Generator to the IVL Catheter and is used to activate lithotripsy energy within the IVL balloon catheter. PPN,QMG Percutaneous Catheter, Ultrasound,Shockwave Intravascular Lithotripsy System 2 Intravascular Lithotripsy (IVL) Connector Cable
17 00195451000348 4.0x40mm S4IVLK4040 The Shockwave S4 Intravascular Lithotripsy (IVL) Catheter consists of an array o The Shockwave S4 Intravascular Lithotripsy (IVL) Catheter consists of an array of miniaturized lithotripsy emitters, located inside a balloon, that generate acoustic pressure waves within the target treatment site, disrupting calcium within the lesion and allowing subsequent dilation of a peripheral artery stenosis using low balloon pressure. Two radiopaque marker bands inside the balloon aid in positioning. The distal catheter and balloon are hydrophilic coated to increase lubricity. The proximal hub has three ports: one for inflation/deflation of the balloon with 50/50 saline/contrast medium, one for the ‘Over-the-wire’ (OTW) guidewire lumen, and one for connection to the IVL Connector Cable (and IVL Generator). OEZ,PPN,JAA Cardiovascular Procedure Kit,Percutaneous Catheter, Ultrasound,System, X-Ray, Fl Cardiovascular Procedure Kit,Percutaneous Catheter, Ultrasound,System, X-Ray, Fluoroscopic, Image-Intensified 2 Shockwave S4
18 00195451000331 3.5x40mm S4IVLK3540 The Shockwave S4 Intravascular Lithotripsy (IVL) Catheter consists of an array o The Shockwave S4 Intravascular Lithotripsy (IVL) Catheter consists of an array of miniaturized lithotripsy emitters, located inside a balloon, that generate acoustic pressure waves within the target treatment site, disrupting calcium within the lesion and allowing subsequent dilation of a peripheral artery stenosis using low balloon pressure. Two radiopaque marker bands inside the balloon aid in positioning. The distal catheter and balloon are hydrophilic coated to increase lubricity. The proximal hub has three ports: one for inflation/deflation of the balloon with 50/50 saline/contrast medium, one for the ‘Over-the-wire’ (OTW) guidewire lumen, and one for connection to the IVL Connector Cable (and IVL Generator). OEZ,PPN,JAA Cardiovascular Procedure Kit,Percutaneous Catheter, Ultrasound,System, X-Ray, Fl Cardiovascular Procedure Kit,Percutaneous Catheter, Ultrasound,System, X-Ray, Fluoroscopic, Image-Intensified 2 Shockwave S4
19 00195451000324 3.0x40mm S4IVLK3040 The Shockwave S4 Intravascular Lithotripsy (IVL) Catheter consists of an array o The Shockwave S4 Intravascular Lithotripsy (IVL) Catheter consists of an array of miniaturized lithotripsy emitters, located inside a balloon, that generate acoustic pressure waves within the target treatment site, disrupting calcium within the lesion and allowing subsequent dilation of a peripheral artery stenosis using low balloon pressure. Two radiopaque marker bands inside the balloon aid in positioning. The distal catheter and balloon are hydrophilic coated to increase lubricity. The proximal hub has three ports: one for inflation/deflation of the balloon with 50/50 saline/contrast medium, one for the ‘Over-the-wire’ (OTW) guidewire lumen, and one for connection to the IVL Connector Cable (and IVL Generator). OEZ,PPN,JAA Cardiovascular Procedure Kit,Percutaneous Catheter, Ultrasound,System, X-Ray, Fl Cardiovascular Procedure Kit,Percutaneous Catheter, Ultrasound,System, X-Ray, Fluoroscopic, Image-Intensified 2 Shockwave S4
20 00195451000317 2.5x40mm S4IVLK2540 The Shockwave S4 Intravascular Lithotripsy (IVL) Catheter consists of an array o The Shockwave S4 Intravascular Lithotripsy (IVL) Catheter consists of an array of miniaturized lithotripsy emitters, located inside a balloon, that generate acoustic pressure waves within the target treatment site, disrupting calcium within the lesion and allowing subsequent dilation of a peripheral artery stenosis using low balloon pressure. Two radiopaque marker bands inside the balloon aid in positioning. The distal catheter and balloon are hydrophilic coated to increase lubricity. The proximal hub has three ports: one for inflation/deflation of the balloon with 50/50 saline/contrast medium, one for the ‘Over-the-wire’ (OTW) guidewire lumen, and one for connection to the IVL Connector Cable (and IVL Generator). OEZ,PPN,JAA Cardiovascular Procedure Kit,Percutaneous Catheter, Ultrasound,System, X-Ray, Fl Cardiovascular Procedure Kit,Percutaneous Catheter, Ultrasound,System, X-Ray, Fluoroscopic, Image-Intensified 2 Shockwave S4
21 00195451000195 7.0 x 60mm M5IVL7060 The Shockwave M5 Intravascular Lithotripsy (IVL) Catheter consists of an array o The Shockwave M5 Intravascular Lithotripsy (IVL) Catheter consists of an array of miniaturized lithotripsy emitters, located inside a balloon, that generate acoustic pressure waves within the target treatment site, disrupting calcium within the lesion and allowing subsequent dilation of a peripheral artery stenosis using low balloon pressure. Two radiopaque marker bands inside the balloon aid in positioning. The proximal hub has three ports: one for inflation/deflation of the balloon with 50/50 saline/contrast medium, one for the ‘Over-the-wire’ (OTW) guidewire lumen, and one for connection to the IVL Connector Cable (and IVL Generator). PPN Percutaneous Catheter, Ultrasound 2 Shockwave M5
22 00195451000188 6.5 x 60mm M5IVL6560 The Shockwave M5 Intravascular Lithotripsy (IVL) Catheter consists of an array o The Shockwave M5 Intravascular Lithotripsy (IVL) Catheter consists of an array of miniaturized lithotripsy emitters, located inside a balloon, that generate acoustic pressure waves within the target treatment site, disrupting calcium within the lesion and allowing subsequent dilation of a peripheral artery stenosis using low balloon pressure. Two radiopaque marker bands inside the balloon aid in positioning. The proximal hub has three ports: one for inflation/deflation of the balloon with 50/50 saline/contrast medium, one for the ‘Over-the-wire’ (OTW) guidewire lumen, and one for connection to the IVL Connector Cable (and IVL Generator). PPN Percutaneous Catheter, Ultrasound 2 Shockwave M5
23 00195451000171 6.0 x 60mm M5IVL6060 The Shockwave M5 Intravascular Lithotripsy (IVL) Catheter consists of an array o The Shockwave M5 Intravascular Lithotripsy (IVL) Catheter consists of an array of miniaturized lithotripsy emitters, located inside a balloon, that generate acoustic pressure waves within the target treatment site, disrupting calcium within the lesion and allowing subsequent dilation of a peripheral artery stenosis using low balloon pressure. Two radiopaque marker bands inside the balloon aid in positioning. The proximal hub has three ports: one for inflation/deflation of the balloon with 50/50 saline/contrast medium, one for the ‘Over-the-wire’ (OTW) guidewire lumen, and one for connection to the IVL Connector Cable (and IVL Generator). PPN Percutaneous Catheter, Ultrasound 2 Shockwave M5
24 00195451000164 5.5 x 60mm M5IVL5560 The Shockwave M5 Intravascular Lithotripsy (IVL) Catheter consists of an array o The Shockwave M5 Intravascular Lithotripsy (IVL) Catheter consists of an array of miniaturized lithotripsy emitters, located inside a balloon, that generate acoustic pressure waves within the target treatment site, disrupting calcium within the lesion and allowing subsequent dilation of a peripheral artery stenosis using low balloon pressure. Two radiopaque marker bands inside the balloon aid in positioning. The proximal hub has three ports: one for inflation/deflation of the balloon with 50/50 saline/contrast medium, one for the ‘Over-the-wire’ (OTW) guidewire lumen, and one for connection to the IVL Connector Cable (and IVL Generator). PPN Percutaneous Catheter, Ultrasound 2 Shockwave M5
25 00195451000157 5.0 x 60mm M5IVL5060 The Shockwave M5 Intravascular Lithotripsy (IVL) Catheter consists of an array o The Shockwave M5 Intravascular Lithotripsy (IVL) Catheter consists of an array of miniaturized lithotripsy emitters, located inside a balloon, that generate acoustic pressure waves within the target treatment site, disrupting calcium within the lesion and allowing subsequent dilation of a peripheral artery stenosis using low balloon pressure. Two radiopaque marker bands inside the balloon aid in positioning. The proximal hub has three ports: one for inflation/deflation of the balloon with 50/50 saline/contrast medium, one for the ‘Over-the-wire’ (OTW) guidewire lumen, and one for connection to the IVL Connector Cable (and IVL Generator). PPN Percutaneous Catheter, Ultrasound 2 Shockwave M5
26 00195451000140 4.5 x 60mm M5IVL4560 The Shockwave M5 Intravascular Lithotripsy (IVL) Catheter consists of an array o The Shockwave M5 Intravascular Lithotripsy (IVL) Catheter consists of an array of miniaturized lithotripsy emitters, located inside a balloon, that generate acoustic pressure waves within the target treatment site, disrupting calcium within the lesion and allowing subsequent dilation of a peripheral artery stenosis using low balloon pressure. Two radiopaque marker bands inside the balloon aid in positioning. The proximal hub has three ports: one for inflation/deflation of the balloon with 50/50 saline/contrast medium, one for the ‘Over-the-wire’ (OTW) guidewire lumen, and one for connection to the IVL Connector Cable (and IVL Generator). PPN Percutaneous Catheter, Ultrasound 2 Shockwave M5
27 00195451000133 4.0 x 60mm M5IVL4060 The Shockwave M5 Intravascular Lithotripsy (IVL) Catheter consists of an array o The Shockwave M5 Intravascular Lithotripsy (IVL) Catheter consists of an array of miniaturized lithotripsy emitters, located inside a balloon, that generate acoustic pressure waves within the target treatment site, disrupting calcium within the lesion and allowing subsequent dilation of a peripheral artery stenosis using low balloon pressure. Two radiopaque marker bands inside the balloon aid in positioning. The proximal hub has three ports: one for inflation/deflation of the balloon with 50/50 saline/contrast medium, one for the ‘Over-the-wire’ (OTW) guidewire lumen, and one for connection to the IVL Connector Cable (and IVL Generator). PPN Percutaneous Catheter, Ultrasound 2 Shockwave M5
28 00195451000126 3.5 x 60mm M5IVL3560 The Shockwave M5 Intravascular Lithotripsy (IVL) Catheter consists of an array o The Shockwave M5 Intravascular Lithotripsy (IVL) Catheter consists of an array of miniaturized lithotripsy emitters, located inside a balloon, that generate acoustic pressure waves within the target treatment site, disrupting calcium within the lesion and allowing subsequent dilation of a peripheral artery stenosis using low balloon pressure. Two radiopaque marker bands inside the balloon aid in positioning. The proximal hub has three ports: one for inflation/deflation of the balloon with 50/50 saline/contrast medium, one for the ‘Over-the-wire’ (OTW) guidewire lumen, and one for connection to the IVL Connector Cable (and IVL Generator). PPN Percutaneous Catheter, Ultrasound 2 Shockwave M5
29 00195451000058 3.0 x 40mm S4IVL3040 The Shockwave S4 Intravascular Lithotripsy (IVL) Catheter consists of an array o The Shockwave S4 Intravascular Lithotripsy (IVL) Catheter consists of an array of miniaturized lithotripsy emitters, located inside a balloon, that generate acoustic pressure waves within the target treatment site, disrupting calcium within the lesion and allowing subsequent dilation of a peripheral artery stenosis using low balloon pressure. Two radiopaque marker bands inside the balloon aid in positioning. The distal catheter and balloon are hydrophilic coated to increase lubricity. The proximal hub has three ports: one for inflation/deflation of the balloon with 50/50 saline/contrast medium, one for the ‘Over-the-wire’ (OTW) guidewire lumen, and one for connection to the IVL Connector Cable (and IVL Generator). PPN Percutaneous Catheter, Ultrasound 2 Shockwave S4
30 M732S4IVL30400 3.0mm x 40mm S4IVL3040 The Shockwave S4 Intravascular Lithotripsy (IVL) Catheter consists of an array o The Shockwave S4 Intravascular Lithotripsy (IVL) Catheter consists of an array of miniaturized lithotripsy emitters, located inside a balloon, that generate acoustic pressure waves within the target treatment site, disrupting calcium within the lesion and allowing subsequent dilation of a peripheral artery stenosis using low balloon pressure. Two radiopaque marker bands inside the balloon aid in positioning. The distal catheter and balloon are hydrophilic coated to increase lubricity. The proximal hub has three ports: one for inflation/deflation of the balloon with 50/50 saline/contrast medium, one for the ‘Over-the-wire’ (OTW) guidewire lumen, and one for connection to the IVL Connector Cable (and IVL Generator). PPN Percutaneous Catheter, Ultrasound 2 Shockwave S4
31 00195451000072 4.0 x 40mm S4IVL4040 The Shockwave S4 Intravascular Lithotripsy (IVL) Catheter consists of an array o The Shockwave S4 Intravascular Lithotripsy (IVL) Catheter consists of an array of miniaturized lithotripsy emitters, located inside a balloon, that generate acoustic pressure waves within the target treatment site, disrupting calcium within the lesion and allowing subsequent dilation of a peripheral artery stenosis using low balloon pressure. Two radiopaque marker bands inside the balloon aid in positioning. The distal catheter and balloon are hydrophilic coated to increase lubricity. The proximal hub has three ports: one for inflation/deflation of the balloon with 50/50 saline/contrast medium, one for the ‘Over-the-wire’ (OTW) guidewire lumen, and one for connection to the IVL Connector Cable (and IVL Generator). PPN Percutaneous Catheter, Ultrasound 2 Shockwave S4
32 00195451000065 3.5 x 40mm S4IVL3540 The Shockwave S4 Intravascular Lithotripsy (IVL) Catheter consists of an array o The Shockwave S4 Intravascular Lithotripsy (IVL) Catheter consists of an array of miniaturized lithotripsy emitters, located inside a balloon, that generate acoustic pressure waves within the target treatment site, disrupting calcium within the lesion and allowing subsequent dilation of a peripheral artery stenosis using low balloon pressure. Two radiopaque marker bands inside the balloon aid in positioning. The distal catheter and balloon are hydrophilic coated to increase lubricity. The proximal hub has three ports: one for inflation/deflation of the balloon with 50/50 saline/contrast medium, one for the ‘Over-the-wire’ (OTW) guidewire lumen, and one for connection to the IVL Connector Cable (and IVL Generator). PPN Percutaneous Catheter, Ultrasound 2 Shockwave S4
33 00195451000041 2.5 x 40mm S4IVL2540 The Shockwave S4 Intravascular Lithotripsy (IVL) Catheter consists of an array o The Shockwave S4 Intravascular Lithotripsy (IVL) Catheter consists of an array of miniaturized lithotripsy emitters, located inside a balloon, that generate acoustic pressure waves within the target treatment site, disrupting calcium within the lesion and allowing subsequent dilation of a peripheral artery stenosis using low balloon pressure. Two radiopaque marker bands inside the balloon aid in positioning. The distal catheter and balloon are hydrophilic coated to increase lubricity. The proximal hub has three ports: one for inflation/deflation of the balloon with 50/50 saline/contrast medium, one for the ‘Over-the-wire’ (OTW) guidewire lumen, and one for connection to the IVL Connector Cable (and IVL Generator). PPN Percutaneous Catheter, Ultrasound 2 Shockwave S4
34 M732S4IVL40400 4.0mm x 40mm S4IVL4040 The Shockwave S4 Intravascular Lithotripsy (IVL) Catheter consists of an array o The Shockwave S4 Intravascular Lithotripsy (IVL) Catheter consists of an array of miniaturized lithotripsy emitters, located inside a balloon, that generate acoustic pressure waves within the target treatment site, disrupting calcium within the lesion and allowing subsequent dilation of a peripheral artery stenosis using low balloon pressure. Two radiopaque marker bands inside the balloon aid in positioning. The distal catheter and balloon are hydrophilic coated to increase lubricity. The proximal hub has three ports: one for inflation/deflation of the balloon with 50/50 saline/contrast medium, one for the ‘Over-the-wire’ (OTW) guidewire lumen, and one for connection to the IVL Connector Cable (and IVL Generator). PPN Percutaneous Catheter, Ultrasound 2 Shockwave S4
35 M732S4IVL35400 3.5mm x 40mm S4IVL3540 The Shockwave S4 Intravascular Lithotripsy (IVL) Catheter consists of an array o The Shockwave S4 Intravascular Lithotripsy (IVL) Catheter consists of an array of miniaturized lithotripsy emitters, located inside a balloon, that generate acoustic pressure waves within the target treatment site, disrupting calcium within the lesion and allowing subsequent dilation of a peripheral artery stenosis using low balloon pressure. Two radiopaque marker bands inside the balloon aid in positioning. The distal catheter and balloon are hydrophilic coated to increase lubricity. The proximal hub has three ports: one for inflation/deflation of the balloon with 50/50 saline/contrast medium, one for the ‘Over-the-wire’ (OTW) guidewire lumen, and one for connection to the IVL Connector Cable (and IVL Generator). PPN Percutaneous Catheter, Ultrasound 2 Shockwave S4
36 M732S4IVL25400 2.5mm x 40mm S4IVL2540 The Shockwave S4 Intravascular Lithotripsy (IVL) Catheter consists of an array o The Shockwave S4 Intravascular Lithotripsy (IVL) Catheter consists of an array of miniaturized lithotripsy emitters, located inside a balloon, that generate acoustic pressure waves within the target treatment site, disrupting calcium within the lesion and allowing subsequent dilation of a peripheral artery stenosis using low balloon pressure. Two radiopaque marker bands inside the balloon aid in positioning. The distal catheter and balloon are hydrophilic coated to increase lubricity. The proximal hub has three ports: one for inflation/deflation of the balloon with 50/50 saline/contrast medium, one for the ‘Over-the-wire’ (OTW) guidewire lumen, and one for connection to the IVL Connector Cable (and IVL Generator). PPN Percutaneous Catheter, Ultrasound 2 Shockwave S4
37 M732M5IVL70600 7.0mm x 60mm M5IVL7060 The Shockwave M5 Intravascular Lithotripsy (IVL) Catheter consists of an array o The Shockwave M5 Intravascular Lithotripsy (IVL) Catheter consists of an array of miniaturized lithotripsy emitters, located inside a balloon, that generate acoustic pressure waves within the target treatment site, disrupting calcium within the lesion and allowing subsequent dilation of a peripheral artery stenosis using low balloon pressure. Two radiopaque marker bands inside the balloon aid in positioning. The proximal hub has three ports: one for inflation/deflation of the balloon with 50/50 saline/contrast medium, one for the ‘Over-the-wire’ (OTW) guidewire lumen, and one for connection to the IVL Connector Cable (and IVL Generator). PPN Percutaneous Catheter, Ultrasound 2 Shockwave M5
38 M732M5IVL65600 6.5mm x 60mm M5IVL6560 The Shockwave M5 Intravascular Lithotripsy (IVL) Catheter consists of an array o The Shockwave M5 Intravascular Lithotripsy (IVL) Catheter consists of an array of miniaturized lithotripsy emitters, located inside a balloon, that generate acoustic pressure waves within the target treatment site, disrupting calcium within the lesion and allowing subsequent dilation of a peripheral artery stenosis using low balloon pressure. Two radiopaque marker bands inside the balloon aid in positioning. The proximal hub has three ports: one for inflation/deflation of the balloon with 50/50 saline/contrast medium, one for the ‘Over-the-wire’ (OTW) guidewire lumen, and one for connection to the IVL Connector Cable (and IVL Generator). PPN Percutaneous Catheter, Ultrasound 2 Shockwave M5
39 M732M5IVL60600 6.0mm x 60mm M5IVL6060 The Shockwave M5 Intravascular Lithotripsy (IVL) Catheter consists of an array o The Shockwave M5 Intravascular Lithotripsy (IVL) Catheter consists of an array of miniaturized lithotripsy emitters, located inside a balloon, that generate acoustic pressure waves within the target treatment site, disrupting calcium within the lesion and allowing subsequent dilation of a peripheral artery stenosis using low balloon pressure. Two radiopaque marker bands inside the balloon aid in positioning. The proximal hub has three ports: one for inflation/deflation of the balloon with 50/50 saline/contrast medium, one for the ‘Over-the-wire’ (OTW) guidewire lumen, and one for connection to the IVL Connector Cable (and IVL Generator). PPN Percutaneous Catheter, Ultrasound 2 Shockwave M5
40 M732M5IVL55600 5.5mm x 60mm M5IVL5560 The Shockwave M5 Intravascular Lithotripsy (IVL) Catheter consists of an array o The Shockwave M5 Intravascular Lithotripsy (IVL) Catheter consists of an array of miniaturized lithotripsy emitters, located inside a balloon, that generate acoustic pressure waves within the target treatment site, disrupting calcium within the lesion and allowing subsequent dilation of a peripheral artery stenosis using low balloon pressure. Two radiopaque marker bands inside the balloon aid in positioning. The proximal hub has three ports: one for inflation/deflation of the balloon with 50/50 saline/contrast medium, one for the ‘Over-the-wire’ (OTW) guidewire lumen, and one for connection to the IVL Connector Cable (and IVL Generator). PPN Percutaneous Catheter, Ultrasound 2 Shockwave M5
41 M732M5IVL50600 5.0mm x 60mm M5IVL5060 The Shockwave M5 Intravascular Lithotripsy (IVL) Catheter consists of an array o The Shockwave M5 Intravascular Lithotripsy (IVL) Catheter consists of an array of miniaturized lithotripsy emitters, located inside a balloon, that generate acoustic pressure waves within the target treatment site, disrupting calcium within the lesion and allowing subsequent dilation of a peripheral artery stenosis using low balloon pressure. Two radiopaque marker bands inside the balloon aid in positioning. The proximal hub has three ports: one for inflation/deflation of the balloon with 50/50 saline/contrast medium, one for the ‘Over-the-wire’ (OTW) guidewire lumen, and one for connection to the IVL Connector Cable (and IVL Generator). PPN Percutaneous Catheter, Ultrasound 2 Shockwave M5
42 M732M5IVL45600 4.5mm x 60mm M5IVL4560 The Shockwave M5 Intravascular Lithotripsy (IVL) Catheter consists of an array o The Shockwave M5 Intravascular Lithotripsy (IVL) Catheter consists of an array of miniaturized lithotripsy emitters, located inside a balloon, that generate acoustic pressure waves within the target treatment site, disrupting calcium within the lesion and allowing subsequent dilation of a peripheral artery stenosis using low balloon pressure. Two radiopaque marker bands inside the balloon aid in positioning. The proximal hub has three ports: one for inflation/deflation of the balloon with 50/50 saline/contrast medium, one for the ‘Over-the-wire’ (OTW) guidewire lumen, and one for connection to the IVL Connector Cable (and IVL Generator). PPN Percutaneous Catheter, Ultrasound 2 Shockwave M5
43 M732M5IVL40600 4.0mm x 60mm M5IVL4060 The Shockwave M5 Intravascular Lithotripsy (IVL) Catheter consists of an array o The Shockwave M5 Intravascular Lithotripsy (IVL) Catheter consists of an array of miniaturized lithotripsy emitters, located inside a balloon, that generate acoustic pressure waves within the target treatment site, disrupting calcium within the lesion and allowing subsequent dilation of a peripheral artery stenosis using low balloon pressure. Two radiopaque marker bands inside the balloon aid in positioning. The proximal hub has three ports: one for inflation/deflation of the balloon with 50/50 saline/contrast medium, one for the ‘Over-the-wire’ (OTW) guidewire lumen, and one for connection to the IVL Connector Cable (and IVL Generator). PPN Percutaneous Catheter, Ultrasound 2 Shockwave M5
44 M732M5IVL35600 3.5mm x 60mm M5IVL3560 The Shockwave M5 Intravascular Lithotripsy (IVL) Catheter consists of an array o The Shockwave M5 Intravascular Lithotripsy (IVL) Catheter consists of an array of miniaturized lithotripsy emitters, located inside a balloon, that generate acoustic pressure waves within the target treatment site, disrupting calcium within the lesion and allowing subsequent dilation of a peripheral artery stenosis using low balloon pressure. Two radiopaque marker bands inside the balloon aid in positioning. The proximal hub has three ports: one for inflation/deflation of the balloon with 50/50 saline/contrast medium, one for the ‘Over-the-wire’ (OTW) guidewire lumen, and one for connection to the IVL Connector Cable (and IVL Generator). PPN Percutaneous Catheter, Ultrasound 2 Shockwave M5
45 00195451000416 12.0x30mm L6IVL120030 The IVL Catheter is a proprietary lithotripsy device delivered through the perip The IVL Catheter is a proprietary lithotripsy device delivered through the peripheral arterial system of the lower extremities to the site of an otherwise difficult to treat calcified stenosis. Energizing the lithotripsy device will generate pulsatile mechanical energy within the target treatment site, disrupting calcium within the lesion and allowing subsequent dilation of a peripheral artery stenosis using low balloon pressure. The IVL Catheter is comprised of an integrated balloon with an array of lithotripsy emitters for the localized delivery of pulsatile mechanical energy. The system consists of an IVL Catheter, an IVL Connector Cable and an IVL Generator. The IVL Catheter is available in four (4) sizes: 8.0 x 30mm, 9.0 x 30mm, 10.0 x 30mm, and 12.0 x 30mm. The L6 Peripheral IVL Catheter is compatible with a 7 or 8F sheath and has a working length of 110cm.The Shockwave L6 Peripheral IVL Catheter shaft contains an inflation lumen, a guidewire lumen, and the lithotripsy emitters. The inflation lumen is used for inflation and deflation of the balloon with 50/50 saline/contrast medium. The guidewire lumen enables the use of a 0.018” guidewire to facilitate advancement of the catheter to and through the target stenosis. The system is designed as ‘Over-the-wire’ (OTW) with 110cm shaft working length, so an exchange length (300cm) guidewire is indicated. The emitters are positioned along the length of the balloon working length for delivery of pulsatile mechanical energy. The balloon is located near the distal tip of the catheter. Two radiopaque marker bands within the balloon denote the length of the balloon to aid in positioning of the balloon during treatment. The balloon is designed to provide an expandable segment of known length and diameter at a specific pressure. The proximal hub has three ports: one for inflation/deflation of the balloon, one for guidewire lumen, and one for connection to the IVL Connector Cable. PPN,OEZ,JAA Percutaneous Catheter, Ultrasound,Cardiovascular Procedure Kit,System, X-Ray, Fl Percutaneous Catheter, Ultrasound,Cardiovascular Procedure Kit,System, X-Ray, Fluoroscopic, Image-Intensified 2 Shockwave Medical L6 Intravascular Lithotripsy (IVL) Catheter
46 00195451000409 10.0x30mm L6IVL100030 The IVL Catheter is a proprietary lithotripsy device delivered through the perip The IVL Catheter is a proprietary lithotripsy device delivered through the peripheral arterial system of the lower extremities to the site of an otherwise difficult to treat calcified stenosis. Energizing the lithotripsy device will generate pulsatile mechanical energy within the target treatment site, disrupting calcium within the lesion and allowing subsequent dilation of a peripheral artery stenosis using low balloon pressure. The IVL Catheter is comprised of an integrated balloon with an array of lithotripsy emitters for the localized delivery of pulsatile mechanical energy. The system consists of an IVL Catheter, an IVL Connector Cable and an IVL Generator. The IVL Catheter is available in four (4) sizes: 8.0 x 30mm, 9.0 x 30mm, 10.0 x 30mm, and 12.0 x 30mm. The L6 Peripheral IVL Catheter is compatible with a 7 or 8F sheath and has a working length of 110cm.The Shockwave L6 Peripheral IVL Catheter shaft contains an inflation lumen, a guidewire lumen, and the lithotripsy emitters. The inflation lumen is used for inflation and deflation of the balloon with 50/50 saline/contrast medium. The guidewire lumen enables the use of a 0.018” guidewire to facilitate advancement of the catheter to and through the target stenosis. The system is designed as ‘Over-the-wire’ (OTW) with 110cm shaft working length, so an exchange length (300cm) guidewire is indicated. The emitters are positioned along the length of the balloon working length for delivery of pulsatile mechanical energy. The balloon is located near the distal tip of the catheter. Two radiopaque marker bands within the balloon denote the length of the balloon to aid in positioning of the balloon during treatment. The balloon is designed to provide an expandable segment of known length and diameter at a specific pressure. The proximal hub has three ports: one for inflation/deflation of the balloon, one for guidewire lumen, and one for connection to the IVL Connector Cable. PPN,OEZ,JAA Percutaneous Catheter, Ultrasound,Cardiovascular Procedure Kit,System, X-Ray, Fl Percutaneous Catheter, Ultrasound,Cardiovascular Procedure Kit,System, X-Ray, Fluoroscopic, Image-Intensified 2 Shockwave Medical L6 Intravascular Lithotripsy (IVL) Catheter
47 00195451000386 8.0x30mm L6IVL080030 The IVL Catheter is a proprietary lithotripsy device delivered through the perip The IVL Catheter is a proprietary lithotripsy device delivered through the peripheral arterial system of the lower extremities to the site of an otherwise difficult to treat calcified stenosis. Energizing the lithotripsy device will generate pulsatile mechanical energy within the target treatment site, disrupting calcium within the lesion and allowing subsequent dilation of a peripheral artery stenosis using low balloon pressure. The IVL Catheter is comprised of an integrated balloon with an array of lithotripsy emitters for the localized delivery of pulsatile mechanical energy. The system consists of an IVL Catheter, an IVL Connector Cable and an IVL Generator. The IVL Catheter is available in four (4) sizes: 8.0 x 30mm, 9.0 x 30mm, 10.0 x 30mm, and 12.0 x 30mm. The L6 Peripheral IVL Catheter is compatible with a 7 or 8F sheath and has a working length of 110cm.The Shockwave L6 Peripheral IVL Catheter shaft contains an inflation lumen, a guidewire lumen, and the lithotripsy emitters. The inflation lumen is used for inflation and deflation of the balloon with 50/50 saline/contrast medium. The guidewire lumen enables the use of a 0.018” guidewire to facilitate advancement of the catheter to and through the target stenosis. The system is designed as ‘Over-the-wire’ (OTW) with 110cm shaft working length, so an exchange length (300cm) guidewire is indicated. The emitters are positioned along the length of the balloon working length for delivery of pulsatile mechanical energy. The balloon is located near the distal tip of the catheter. Two radiopaque marker bands within the balloon denote the length of the balloon to aid in positioning of the balloon during treatment. The balloon is designed to provide an expandable segment of known length and diameter at a specific pressure. The proximal hub has three ports: one for inflation/deflation of the balloon, one for guidewire lumen, and one for connection to the IVL Connector Cable. PPN,OEZ,JAA Percutaneous Catheter, Ultrasound,Cardiovascular Procedure Kit,System, X-Ray, Fl Percutaneous Catheter, Ultrasound,Cardiovascular Procedure Kit,System, X-Ray, Fluoroscopic, Image-Intensified 2 Shockwave Medical L6 Intravascular Lithotripsy (IVL) Catheter
48 00195451000270 7.0x60mm M5PIVL7060 The Shockwave M5+ Intravascular Lithotripsy (IVL) Catheter consists of an array The Shockwave M5+ Intravascular Lithotripsy (IVL) Catheter consists of an array of miniaturized lithotripsy emitters, located inside a balloon, that generate acoustic pressure waves within the target treatment site, disrupting calcium within the lesion and allowing subsequent dilation of a peripheral artery stenosis using low balloon pressure. Two radiopaque marker bands inside the balloon aid in positioning. The proximal hub has three ports: one for inflation/deflation of the balloon with 50/50 saline/contrast medium, one for the ‘Over-the-wire’ (OTW) guidewire lumen, and one for connection to the IVL Connector Cable (and IVL Generator). OEZ,JAA,PPN Cardiovascular Procedure Kit,System, X-Ray, Fluoroscopic, Image-Intensified,Perc Cardiovascular Procedure Kit,System, X-Ray, Fluoroscopic, Image-Intensified,Percutaneous Catheter, Ultrasound 2 Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave M5+
49 00195451000287 8.0x60mm M5PIVL8060 The Shockwave M5+ Intravascular Lithotripsy (IVL) Catheter consists of an array The Shockwave M5+ Intravascular Lithotripsy (IVL) Catheter consists of an array of miniaturized lithotripsy emitters, located inside a balloon, that generate acoustic pressure waves within the target treatment site, disrupting calcium within the lesion and allowing subsequent dilation of a peripheral artery stenosis using low balloon pressure. Two radiopaque marker bands inside the balloon aid in positioning. The proximal hub has three ports: one for inflation/deflation of the balloon with 50/50 saline/contrast medium, one for the ‘Over-the-wire’ (OTW) guidewire lumen, and one for connection to the IVL Connector Cable (and IVL Generator). OEZ,JAA,PPN Cardiovascular Procedure Kit,System, X-Ray, Fluoroscopic, Image-Intensified,Perc Cardiovascular Procedure Kit,System, X-Ray, Fluoroscopic, Image-Intensified,Percutaneous Catheter, Ultrasound 2 Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave M5+
50 00195451000263 6.5x60mm M5PIVL6560 The Shockwave M5+ Intravascular Lithotripsy (IVL) Catheter consists of an array The Shockwave M5+ Intravascular Lithotripsy (IVL) Catheter consists of an array of miniaturized lithotripsy emitters, located inside a balloon, that generate acoustic pressure waves within the target treatment site, disrupting calcium within the lesion and allowing subsequent dilation of a peripheral artery stenosis using low balloon pressure. Two radiopaque marker bands inside the balloon aid in positioning. The proximal hub has three ports: one for inflation/deflation of the balloon with 50/50 saline/contrast medium, one for the ‘Over-the-wire’ (OTW) guidewire lumen, and one for connection to the IVL Connector Cable (and IVL Generator). OEZ,JAA,PPN Cardiovascular Procedure Kit,System, X-Ray, Fluoroscopic, Image-Intensified,Perc Cardiovascular Procedure Kit,System, X-Ray, Fluoroscopic, Image-Intensified,Percutaneous Catheter, Ultrasound 2 Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave M5+
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