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Shockwave Medical IVL Generator and Connector Cable

FDA UDI

Class II (US FDA UDI)

by Shockwave Medical, Inc.

Identity

Trade Name
Shockwave Medical IVL Generator and Connector Cable FDA UDI
Generic Name
Ultrasound thrombolysis system catheter, peripheral FDA UDI
Device Name
The Shockwave Medical Intravascular Lithotripsy (IVL) Connector Cable is a remote actuator which connects the IVL Generator to the IVL Catheter and is used to activate lithotripsy energy within the IVL balloon catheter. FDA UDI
Model / Reference
IVLCC FDA UDI
Description
The Shockwave Medical Intravascular Lithotripsy (IVL) Connector Cable is a remote actuator which connects the IVL Generator to the IVL Catheter and is used to activate lithotripsy energy within the IVL balloon catheter. FDA UDI

Identifiers

Catalog Number
IVLCC FDA UDI
Primary DI / UDI-DI
M732IVLCC0 FDA UDI
FDA Product Code
PPN FDA UDI
QMG FDA UDI
GMDN Term
Ultrasound thrombolysis system catheter, peripheral FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
870.1250 FDA UDI
Commercial Distribution
Not in Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

Shockwave Medical IVL Generator and Connector Cable by Shockwave Medical, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Shockwave Medical, Inc.

Sources (1)

  • FDA UDI a805d129-8e95-4794-bf48-d5cadd373b67 36 fields · synced May 30, 2026