Shockwave Intravascular Lithotripsy (IVL) Generator and Connector Cable

Basic Information

• Brand Name: Shockwave Intravascular Lithotripsy (IVL) Generator and Connector Cable
• Primary DI: 00195451000294
• Version / Model: 825D
• Catalog Number: IVLGCCD
• Company Name: Shockwave Medical, Inc.
• Labeler DUNS: 055514478
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2021-02-11
• Public Version: 4
• Public Version Date: 2023-04-05
• Public Version Status: Update
• Public Device Record Key: c4ada0a6-1e37-4c2a-80a3-cfd44e88902a

Device Description

The Shockwave Medical Inc. IVL Generator and Connector Cable provides power and exchanges data via a Connector Cable to the IVL Catheters, which deliver localized lithotripsy-enhanced balloon dilatation of calcified stenotic peripheral arteries.

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• 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: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
PPN	Percutaneous Catheter, Ultrasound	Cardiovascular	870.1250	2
QMG	Shockwave Intravascular Lithotripsy System	Unknown		3

GMDN Terms

Code	Name	Definition	Implantable	Status
66728	Intravascular lithotripsy system balloon catheter, coronary	An electrically-powered, flexible tube intended to be introduced into a coronary 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
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
66730	Intravascular lithotripsy system generator	An electrically-powered device intended to produce electrical current for transmission to an appropriate catheter (not included) to perform intravascular lithotripsy in peripheral and/or coronary arteries. It typically includes controls, display, and connection cables. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00195451000294	GS1
Previous	M732IVLGCCD0	HIBCC

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K191840	000
P200039	000

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 10 – 35 Degrees Celsius
• Type: Storage Environment Humidity
• Temperature Range: 10 – 70 Percent (%) Relative Humidity