Shockwave Medical, Inc.

Shockwave M5 - M732M5IVL45600 Catalog Number : M5IVL4560

Device Description : 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).

Device Class : 2

Duns Number: 055514478

Premarket Exempt : No

Product Code : PPN

Prescription Use : Yes

Device Count : 1

Shockwave M5 - M732M5IVL50600 Catalog Number : M5IVL5060

Device Description : 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).

Device Class : 2

Duns Number: 055514478

Premarket Exempt : No

Product Code : PPN

Prescription Use : Yes

Device Count : 1

Shockwave M5 - M732M5IVL55600 Catalog Number : M5IVL5560

Device Description : 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).

Device Class : 2

Duns Number: 055514478

Premarket Exempt : No

Product Code : PPN

Prescription Use : Yes

Device Count : 1

Shockwave M5 - M732M5IVL60600 Catalog Number : M5IVL6060

Device Description : 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).

Device Class : 2

Duns Number: 055514478

Premarket Exempt : No

Product Code : PPN

Prescription Use : Yes

Device Count : 1

Shockwave M5 - M732M5IVL65600 Catalog Number : M5IVL6560

Device Description : 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).

Device Class : 2

Duns Number: 055514478

Premarket Exempt : No

Product Code : PPN

Prescription Use : Yes

Device Count : 1

Shockwave M5 - M732M5IVL70600 Catalog Number : M5IVL7060

Device Description : 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).

Device Class : 2

Duns Number: 055514478

Premarket Exempt : No

Product Code : PPN

Prescription Use : Yes

Device Count : 1

Shockwave S4 - M732S4IVL25400 Catalog Number : S4IVL2540

Device Description : 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).

Device Class : 2

Duns Number: 055514478

Premarket Exempt : No

Product Code : PPN

Prescription Use : Yes

Device Count : 1

Shockwave S4 - M732S4IVL30400 Catalog Number : S4IVL3040

Device Description : 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).

Device Class : 2

Duns Number: 055514478

Premarket Exempt : No

Product Code : PPN

Prescription Use : Yes

Device Count : 1

Shockwave S4 - M732S4IVL35400 Catalog Number : S4IVL3540

Device Description : 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).

Device Class : 2

Duns Number: 055514478

Premarket Exempt : No

Product Code : PPN

Prescription Use : Yes

Device Count : 1

Shockwave S4 - M732S4IVL40400 Catalog Number : S4IVL4040

Device Description : 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).

Device Class : 2

Duns Number: 055514478

Premarket Exempt : No

Product Code : PPN

Prescription Use : Yes

Device Count : 1

Shockwave Medical, Inc.

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