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: Electrical catheter connection cable/switch 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: 00195451000300 FDA UDI
PMA Number: P200039 FDA UDI
510(k) Number: K191840 FDA UDI
FDA Product Code: PPN FDA UDI
QMG FDA UDI
GMDN Term: Electrical catheter connection cable/switch FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 870.1250 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Electrical catheter connection cable/switch

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

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Cleared under the same submission

K191840 also covers:

P200039 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Shockwave Medical, Inc.

Sources (1)

FDA UDI 421d8bdf-9e78-47c3-b2b9-fb74f6e34e50 36 fields · synced May 30, 2026