Shockwave Intravascular Lithotripsy IVL System with Shockwave C2+ Coronary Intravascular Lithotripsy IVL Catheter

FDA PMAFDA 510(k)EUDAMED

Class III (US FDA PMA)

PMA P200039510(k) K180454

by Shockwave Medical, Inc.

Identity

Trade Name: Shockwave Intravascular Lithotripsy (IVL) System with Shockwave C2 Coronary Intravascular Lithotripsy (IVL) Catheter FDA PMA
Generic Name: Shockwave intravascular lithotripsy system FDA PMA

Identifiers

PMA Number: P200039 FDA PMA
510(k) Number: K180454 FDA PMA
FDA Product Code: PPN FDA PMA

Classification

Device Class: Class II FDA PMA
Legislation / Framework: 21 CFR Part 870.1250 FDA PMA
Regulation Number: 870.1250 FDA PMA
Advisory Committee: Cardiovascular FDA PMA
FDA Decision: SESE Substantially Equivalent FDA PMA

The Shockwave Intravascular Lithotripsy (IVL) System with Shockwave C2+ Coronary Intravascular Lithotripsy (IVL) Catheter is a specialized medical device designed for the treatment of severely calcified, stenotic de novo coronary arteries. It utilizes lithotripsy-enabled, low-pressure balloon dilatation to modify calcified plaques within the vessel wall prior to the placement of a stent.

This system is intended for use by medical professionals in a clinical setting to facilitate the preparation of coronary arteries. The device is regulated under FDA and MDR authorizations, ensuring it meets established safety and performance standards for cardiovascular interventions. Users should refer to the specific product labeling for guidance on clinical application and procedural requirements.

Frequently asked questions

What is the primary function of the Shockwave IVL System?

The system is designed for lithotripsy-enabled, low-pressure balloon dilatation, which helps to fracture and modify severely calcified plaques in coronary arteries before a stent is implanted.

Is this device intended for use in all coronary artery procedures?

No, the device is specifically indicated for the treatment of severely calcified, stenotic de novo coronary arteries prior to stenting.

What regulatory oversight does this device have?

The Shockwave Intravascular Lithotripsy System is subject to regulatory authorizations including FDA 510(k) clearance, FDA PMA approval, and MDR compliance.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Shockwave.com - FREE Online Games & Download Games, Shockwave Medical, Shockwave C2+ - Shockwave Medical

Authorization Coverage (2 countries)

Regulatory Authorizations

United States Active

FDA_510K

European Union Active

MDR

United States Active

FDA_PMA

Source	Region	Type	Cert / Approval No.	Class	Status
FDA 510(k)	United States	FDA_510K	K180454	Class III	Active
EUDAMED	European Union	MDR	—	Class III	Active
FDA PMA	United States	FDA_PMA	P200039	Class III	Active

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Manufacturer

Manufacturer: Shockwave Medical, Inc.

Sources (3)

FDA PMA P200039 37 fields · synced Sep 18, 2026
FDA 510(k) K180454 1 fields · synced May 18, 2026
EUDAMED 1 fields · synced May 17, 2026