Lithoplasty®

FDA UDI

Class II (US FDA UDI)

by Shockwave Medical, Inc.

Identity

Trade Name: Lithoplasty® FDA UDI
Generic Name: Ultrasound thrombolysis system control unit FDA UDI
Device Name: The Shockwave Medical Inc. Lithoplasty® Generator provides power and exchanges data via a Connector Cable to the Lithoplasty® Catheters, which deliver localized lithotripsy-enhanced balloon dilatation of calcified stenotic peripheral arteries. FDA UDI
Model / Reference: M732LGCC825DX1 FDA UDI
Description: The Shockwave Medical Inc. Lithoplasty® Generator provides power and exchanges data via a Connector Cable to the Lithoplasty® Catheters, which deliver localized lithotripsy-enhanced balloon dilatation of calcified stenotic peripheral arteries. FDA UDI

Identifiers

Catalog Number: M732LGCC825DX1 FDA UDI
Primary DI / UDI-DI: M732LGCC825DX1 FDA UDI
FDA Product Code: PPN FDA UDI
GMDN Term: Ultrasound thrombolysis system control unit 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: Ultrasound thrombolysis system control unit

Lithoplasty® by Shockwave Medical, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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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 18c707e5-1585-4a47-92db-5e24b3df5afb 36 fields · synced May 30, 2026