Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave M5+

Basic Information

• Brand Name: Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave M5+
• Primary DI: 00195451000232
• Version / Model: 5.0x60mm
• Catalog Number: M5PIVL5060
• Company Name: Shockwave Medical, Inc.
• Labeler DUNS: 055514478
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2021-05-11
• Public Version: 4
• Public Version Date: 2023-04-05
• Public Version Status: Update
• Public Device Record Key: d43053e1-e654-42f7-88ab-b2398a937846

Device 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).

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: Yes
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
OEZ	Cardiovascular Procedure Kit	Cardiovascular	870.1200	2
JAA	System, X-Ray, Fluoroscopic, Image-Intensified	Radiology	892.1650	2
PPN	Percutaneous Catheter, Ultrasound	Cardiovascular	870.1250	2

GMDN Terms

Code	Name	Definition	Implantable	Status
66729	Intravascular lithotripsy system balloon catheter, peripheral	An electrically-powered, flexible tube intended to be introduced into a peripheral artery stiffened by a highly calcified atheromatous plaque, to transmit ultrasound (US) waves [e.g., acoustic pressure pulses] for the disruption of the plaque to improve vessel compliance. It is used in conjunction with a dedicated control unit/generator (not included) and includes transducers intended to convert electrical energy to ultrasound and an inflatable balloon at its distal end to facilitate energy transmission and dilation of the vessel. This is a single-use device.	No	Active
12535	Medical equipment drape, single-use	A flexible polymer sheet/bag/sleeve designed to form a protective water-resistant enclosure around a piece of medical equipment (e.g., C-arm, surgical laser/camera/microscope, examination table/chair) and/or equipment components (e.g., cables, tubes, headrest). It is intended as a hygienic barrier to protect the contents from soiling and contamination when used in the vicinity of, or entered into, a hygienic area. It is neither a dedicated handle cover, device cap nor an ultrasound transducer cover. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00195451000232	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Device Sizes

Type	Value	Unit	Text
Catheter Working Length	135	Centimeter
Balloon Diameter	5.0	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

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Keep dry and keep away from heat