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Shockwave Medical, Inc. M5PIVL6560 Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave M5+

Company Name

Shockwave Medical, Inc.

Catalog Number

M5PIVL6560

Device Size

Catheter Working Length: 135 Centimeter
Balloon Diameter: 6.5 Millimeter
Balloon Nominal (Inflation) Pressure: 6 Atmosphere
Balloon Rated Burst Pressure: 10 Atmosphere
Balloon Length: 60 Millimeter
Introducer Sheath Compatibility: 6 French
Balloon Proximal Outer Diameter (OD): 0.078 Inch
Guidewire Diameter: 0.014 Inch

Description

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).

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Additional Details

Device Identifier

00195451000263

Is RX

Yes

Is Over the Counter

No

Requires Sterilization

No

Is Sterile

Yes

Is Single Use

Yes

Categories

Barcode Mapping

Unit of Measurement	Eaches	GTIN
Each	1	00195451000263