Data / Medical devices / United States / Shockwave Medical, Inc.

Shockwave Medical, Inc.: FDA-registered device maker in Santa Clara, CA, United States, 13 510(k) clearances and 1 PMA approval

Name: Shockwave Medical, Inc. FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Shockwave Medical, Inc. is registered with the FDA (registration 3015053858) in Santa Clara, CA, United States. It lists 4 device types. The FDA files 13 510(k) clearances and 1 PMA approval under its listings, the newest dated July 27, 2026. 1 recall event names it as the recalling firm. Registered through 2027. FDA data exported November 2, 2026.

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FDA registration number: 3015053858
Address: 5403 Betsy Ross Drive, Santa Clara, CA, United States, 95054
Owner or operator: Shockwave Medical, Inc. (10046972)
Roles: Complaint file establishment, Manufacturer, Repackager or relabeler, Specification developer
First device listed: September 23, 2016
Registered through: 2027
Brand names listed: Lithoplasty Peripheral Balloon Dilatation Catheter, Peripheral Intravascular Lithotripsy (IVL) System, Shockwave C2, Shockwave C2 Aero Coronary IVL Catheter, Shockwave C2 Aero Fly Coronary IVL Catheter, Shockwave C2 Catheter, Shockwave C2 Coronary Intravascular Lithotripsy (IVL) Catheter, Shockwave C2+ and more

Devices it lists

Device	Product code	Class	Role	Source
Cardiovascular Procedure Kit	OEZ	2	Complaint file establishment, Manufacturer, Repackager or relabeler, Specification developer	accessdata.fda.gov
Catheter, Percutaneous	DQY	2	Complaint file establishment, Manufacturer	accessdata.fda.gov
Percutaneous Catheter, Ultrasound	PPN	2	Complaint file establishment, Manufacturer, Repackager or relabeler, Specification developer	accessdata.fda.gov
Shockwave Intravascular Lithotripsy System	QMG	3	Complaint file establishment, Manufacturer, Repackager or relabeler, Specification developer	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
July 27, 2026	K262201	Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave E8 Peripheral IVL Catheter	PPN	Substantially Equivalent	Shockwave Medical, Inc.	accessdata.fda.gov
May 2, 2025	K243757	Shockwave CS Guide Catheter	DQY	Substantially Equivalent	Shockwave Medical, Inc.	accessdata.fda.gov
September 27, 2024	K242213	Shockwave Intravascular Lithotripsy (IVL) System with the Javelin Peripheral Intravascular Lithotripsy (IVL) Catheter	PPN	Substantially Equivalent	Shockwave Medical, Inc.	accessdata.fda.gov
May 7, 2024	K240954	Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave L6 Peripheral IVL Catheter	PPN	Substantially Equivalent	Shockwave Medical, Inc.	accessdata.fda.gov
March 22, 2024	K240225	Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave E8 Peripheral IVL Catheter	PPN	Substantially Equivalent	Shockwave Medical, Inc.	accessdata.fda.gov
August 16, 2022	K221852	Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave L6 Peripheral IVL Catheter	PPN	Substantially Equivalent	Shockwave Medical, Inc.	accessdata.fda.gov
April 25, 2022	K221041	Shockwave Medical Peripheral Intravascular Lithotripsy (IVL) System	PPN	Substantially Equivalent	Shockwave Medical, Inc.	accessdata.fda.gov
April 22, 2021	K203365	Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave M5+ Peripheral IVL Catheter	PPN	Substantially Equivalent	Shockwave Medical, Inc.	accessdata.fda.gov
August 7, 2019	K191840	Peripheral Intravascular Lithotripsy (IVL) Catheters, IVL Generator and Connector Cable Kit, IVL Connector Cable (Replacement)	PPN	Substantially Equivalent	Shockwave Medical, Inc.	accessdata.fda.gov
July 26, 2018	K180958	Shockwave M5 Peripheral Intravascular Lithotripsy (IVL) Catheter, lntravascular Lithotripsy (IVL) Generator And Connector Cable, Intravascular Lithotripsy (IVL) Connector Cable	PPN	Substantially Equivalent	Shockwave Medical, Inc.	accessdata.fda.gov
June 27, 2018	K180454	Shockwave Medical Intravascular Lithotripsy (IVL) System	PPN	Substantially Equivalent	Shockwave Medical, Inc.	accessdata.fda.gov
December 22, 2016	K163306	Lithoplasty Peripheral Balloon Dilatation Catheter; Lithoplasty Generator And Connector Cable; Lithoplasty Connector Cable	PPN	Substantially Equivalent	Shockwave Medical, Inc.	accessdata.fda.gov
September 14, 2016	K161384	Lithoplasty Peripheral Balloon Dilatation Catheter, Lithoplasty Generator and Connector Cable, Lithoplasty Connector Cable	PPN	Substantially Equivalent	Shockwave Medical, Inc.	accessdata.fda.gov

PMA approvals

Premarket approvals this establishment lists, with the supplements the FDA has decided since.

Approved	PMA number	Device	Product code	Supplements	Latest decision	Source
February 12, 2021	P200039	Shockwave Intravascular Lithotripsy (IVL) System with Shockwave C2 Coronary Intravascular Lithotripsy (IVL) Catheter	QMG	24	September 11, 2026	accessdata.fda.gov

Recalls

Recall events where this establishment is the recalling firm, matched on its FEI.

Initiated	Event	Class	Status	Product	Reason	Source
July 18, 2018	80865	Class II	Terminated	The Shockwave S4 IVL Catheters are intended for lithotripsy-enhanced balloon dilatation of lesions, including calcified lesions, in the peripheral vasculature, including the iliac, femoral, ilio-femoral, popliteal, infra	Catheter unable to maintain inflation pressure during treatment (4ATM) and/or during IVL post dilatation (at 6ATM).	accessdata.fda.gov

Compare with other makers

Updated September 11, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.