Other products from "RESOURCE OPTIMIZATION & INNOVATION, L.L.C."
No Primary DI Version or Model Catalog Number Device Description Product Code Product Code Name Device Class Brand Name
1 00326053116087 370003 PEZ Central Venous Catheter Dressing Change Kit 2 Regard™
2 10326053115179 GS1031 FDE Laparoscopy Kit 2 Regard™
3 10326053110051 NU0527 OJG Neurological Tray 1 Regard™
4 10326053109727 OR0354 OJH Orthopedic Tray 1 Regard™
5 10326053108959 GS0775 FDE Laparoscopy Kit 2 Regard™
6 10326053108621 GS0420 LRO General Surgery Tray 2 Regard™
7 10326053108461 HT0331 OES Cardiac Catheterization Kit 2 Regard™
8 10326053108300 GS0445 LRO General Surgery Tray 2 Regard™
9 10326053107983 GS0681 LRO General Surgery Tray 2 Regard™
10 10326053106979 CV0364 OEQ Angiography/Angioplasty Kit 2 Regard™
11 10326053100434 OR0047 OJH Orthopedic Tray 1 Regard™
12 10326053100083 GS0008 LRO General Surgery Tray 2 Regard™
13 10326053113434 GS0904 LRO General Surgery Tray 2 Regard
14 10326053113229 HT0870 OES Cardiac Catheterization Kit 2 Regard
15 00326053117435 A2ISOGXLNS-REG GOWN ISOL PULLOVER AAMI2 XL OEA Non-Surgical Isolation Gown 1 Regard
16 00326053117428 A2ISOGULNS-REG GOWN ISOL PULLOVER AAMI2 UNIV OEA Non-Surgical Isolation Gown 1 Regard
17 00326053117763 A3ISRGSTXXL-REG AAMI Level 3 Surgical Gown, Reinforced SMS, Sterile XX Large FYA Gown, Surgical 2 Regard
18 00326053117756 A3ISRGSTXL-REG AAMI Level 3 Surgical Gown, Reinforced SMS, Sterile X Large FYA Gown, Surgical 2 Regard
19 00326053117749 GGLDSPUL-REG Goggles Without Ventilation, Universal Size HOY Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear) 1 Regard
20 00326053117619 A1PMSKELUL-REG 382966 AAMI LEVEL 1, PROCEDURE MASK, EARLOOP, GREEN, NON STERILE, UNIVERSAL SIZE FXX Mask, Surgical 2 Regard
21 00326053117442 A2ISOG2XLNS-REG GOWN ISOL PULLOVER AAMI2 2XL OEA Non-Surgical Isolation Gown 1 Regard
22 00326053117602 66-3130-S 382965 Set-in Sleeve AAMI 3 Sterile Surgical Gown, Size XL FYA Gown, Surgical 2 SurgiPlus
23 00326053116650 382982 LRS I.V. Start Kit 2 Regard™
24 00326053115943 361066 PEZ Central Venous Catheter Dressing Change Kit 2 Regard™
25 10326053119054 DSPSCRBSHTGRXXL-RG DSPSCRBSHTGRXXL-RG Scrub Shirt Disposable 2XL Green no pocket LYU Accessory, Surgical Apparel 1 Regard™
26 00326053105661 PEDIATRIC-ZOLL 315728REG MLN Electrode, Electrocardiograph, Multi-Function 2 Regard™
27 00326053105654 PED-100 315727REG MLN Electrode, Electrocardiograph, Multi-Function 2 Regard™
28 00326053105555 315717 MLN Electrode, Electrocardiograph, Multi-Function 2 Regard™
29 00326053105517 T100AC-PHILIPS 315713REG MLN Electrode, Electrodcardiograph, Multi-Function 2 Regard™
30 00326053105500 T100AC-PHYSIO 315712REG MLN Electrode, Electrodcardiograph, Multi-Function 2 Regard™
31 00326053105494 T100AC-ZOLL 315711REG MLN Electrode, Electrodcardiograph, Multi-Function 2 Regard™
32 00326053105487 T100AC 315710REG MLN Electrode, Electrodcardiograph, Multi-Function 2 Regard™
33 00326053105470 315709 MLN Electrode, Electrocardiograph, Multi-Function 2 Regard™
34 00326053105463 315708 MLN Electrode, Electrocardiograph, Multi-Function 2 Regard™
35 00326053105456 315707 MLN Electrode, Electrocardiograph, Multi-Function 2 Regard™
36 00326053105012 303413 FLL Thermometer, Electronic, Clinical Regard™
37 20326053106006 C100AC-ZOLL 335560REG MLN Electrode, Electrodcardiograph, Multi-Function 2 Regard™
38 30326053104825 315673REG 315673REG LUBRICATING JELLY, 2OZ TUBE KMJ Lubricant, Patient Regard™
39 30326053102685 70512ROI GAB Needle, Suturing, Disposable Regard™
40 30326053102678 70412ROI COUNTER NDLE FM BLK W/ MAGNT GAB Needle, Suturing, Disposable Regard™
41 30326053102654 236170 GAB Needle, Suturing, Disposable Regard™
42 20326053105306 303408 PEZ Central Venous Catheter Dressing Change Kit 2 Regard™
43 20326053105290 303407 PEZ Central Venous Catheter Dressing Change Kit 2 Regard™
44 20326053105283 303406 PEZ Central Venous Catheter Dressing Change Kit 2 Regard™
45 20326053105269 303404 LRS I.V. Start Kit 2 Regard™
46 20326053105252 303403 LRS I.V. Start Kit 2 Regard™
47 20326053105214 303399 PEZ Central Venous Catheter Dressing Change Kit 2 Regard™
48 20326053105207 303398 LRO General Surgery Tray 2 Regard™
49 20326053105184 303396 OVN Suture Kit 2 Regard™
50 20326053105160 303394 OFF Central Venous Catheter Tray 2 Regard™
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1 00827002236523 G23652 MSB-TRAY-DRY Maximal Sterile Barrier Bedside Tray Cook COOK INCORPORATED
2 00827002208995 G20899 MSB-TRAY Maximal Sterile Barrier Bedside Tray Cook COOK INCORPORATED
3 00811870035555 CLT-19914 Custom Healthcare Systems of VA, LLC CUSTOM HEALTHCARE SYSTEMS, INC.
4 00811870035371 KM-CBMT Custom Healthcare Systems of VA, LLC CUSTOM HEALTHCARE SYSTEMS, INC.
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6 00811870033216 UNC-17914 Custom Healthcare Systems Inc. CUSTOM HEALTHCARE SYSTEMS, INC.
7 00811870032479 M100 Custom Healthcare Systems Inc. CUSTOM HEALTHCARE SYSTEMS, INC.
8 00811870032172 CDWS-19145 Custom Healthcare Systems Inc. CUSTOM HEALTHCARE SYSTEMS, INC.
9 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. Shockwave Medical L6 Intravascular Lithotripsy (IVL) Catheter SHOCKWAVE MEDICAL, INC.
10 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. Shockwave Medical L6 Intravascular Lithotripsy (IVL) Catheter SHOCKWAVE MEDICAL, INC.
11 00195451000393 9.0x30mm L6IVL090030 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. Shockwave Medical L6 Intravascular Lithotripsy (IVL) Catheter SHOCKWAVE MEDICAL, INC.
12 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. Shockwave Medical L6 Intravascular Lithotripsy (IVL) Catheter SHOCKWAVE MEDICAL, INC.
13 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). Shockwave S4 SHOCKWAVE MEDICAL, INC.
14 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). Shockwave S4 SHOCKWAVE MEDICAL, INC.
15 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). Shockwave S4 SHOCKWAVE MEDICAL, INC.
16 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). Shockwave S4 SHOCKWAVE MEDICAL, INC.
17 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). Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave M5+ SHOCKWAVE MEDICAL, INC.
18 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). Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave M5+ SHOCKWAVE MEDICAL, INC.
19 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). Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave M5+ SHOCKWAVE MEDICAL, INC.
20 00195451000256 6.0x60mm M5PIVL6060 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). Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave M5+ SHOCKWAVE MEDICAL, INC.
21 00195451000249 5.5x60mm M5PIVL5560 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). Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave M5+ SHOCKWAVE MEDICAL, INC.
22 00195451000232 5.0x60mm M5PIVL5060 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). Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave M5+ SHOCKWAVE MEDICAL, INC.
23 00195451000225 4.5x60mm M5PIVL4560 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). Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave M5+ SHOCKWAVE MEDICAL, INC.
24 00195451000218 4.0x60mm M5PIVL4060 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). Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave M5+ SHOCKWAVE MEDICAL, INC.
25 00195451000201 3.5x60mm M5PIVL3560 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). Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave M5+ SHOCKWAVE MEDICAL, INC.
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