Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3015053858

FEI Number

3015053858

Entity Name

SHOCKWAVE MEDICAL, INC.

City/State/Country

Santa Clara, CA, US

Establishment Address

5403 Betsy Ross Drive, Santa Clara, CA 95054, US

Establishment Type(s)

Repack or Relabel Medical Device,Develop Specifications But Do Not Manufacture At This Facility,Complaint File Establishment per 21 CFR 820.198,Manufacture Medical Device

Owner / Operator

Shockwave Medical, Inc. (Owner Number: 10046972)

Owner / Operator Contact Address

5403 Betsy Ross Drive, Santa Clara, CA 95054, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K180454

PMA Number

N/A

All Registered Proprietary Names

Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave L6 Peripheral IVL Catheter Shockwave Medical, Inc. Peripheral Lithoplasty System Lithoplasty Peripheral Balloon Dilatation Catheter Shockwave S4 IVL Catheter Shockwave Medical, Inc. Peripheral Intravascular Lithotripsy (IVL) System Shockwave M5 IVL Catheter Shockwave Medical Peripheral Lithoplasty System Shockwave Medical Intravascular Lithotripsy (IVL) Generator and Connector Cable Shockwave S4 Intravascular Lithotripsy (IVL) Catheter Shockwave Medical Intravascular Lithotripsy (IVL) Connector Cable Shockwave M5 Intravascular Lithotripsy (IVL) Catheter Shockwave Intravascular Lithotripsy (IVL) System with the Javelin Peripheral Intravascular Lithotripsy (IVL) Catheter Shockwave Medical, Inc. Peripheral Lithoplasty System Shockwave S4 IVL Catheter Shockwave Medical, Inc. Peripheral Intravascular Lithotripsy (IVL) System Shockwave M5 IVL Catheter Lithoplasty Peripheral Balloon Dilatation Catheter Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave M5+ Peripheral IVL Catheter Shockwave Intravascular Lithotripsy (IVL) Generator and Connector Cable Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave M5+ IVL Catheter Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave S4 IVL Catheter Shockwave Intravascular Lithotripsy (IVL) System with the Javelin Peripheral Intravascular Lithotripsy (IVL) Catheter Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave L6 Peripheral IVL Catheter Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave E8 Peripheral IVL Catheter Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave C2+ Coronary IVL Catheter Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave L6 Peripheral IVL Catheter Shockwave C2+ Shockwave C2 Aero Fly Coronary IVL Catheter Shockwave C2 Shockwave Intravascular Lithotripsy (IVL) System with Shockwave C2 Coronary IVL Catheter Shockwave C2 Coronary Intravascular Lithotripsy (IVL) Catheter Shockwave C2 Catheter Shockwave C2 Aero Coronary IVL Catheter Shockwave Intravascular Lithotripsy System with Shockwave C2+ Coronary IVL Catheter Shockwave C2+ Coronary IVL Catheter Shockwave CS Guide Catheter Peripheral Intravascular Lithotripsy (IVL) System Shockwave Medical Intravascular Lithotripsy (IVL) Connector Cable Shockwave S4 Intravascular Lithotripsy (IVL) Catheter Shockwave M5 Intravascular Lithotripsy (IVL) Catheter Shockwave Medical Intravascular Lithotripsy (IVL) Generator and Connector Cable Shockwave Medical Peripheral Lithoplasty System Lithoplasty Peripheral Balloon Dilatation Catheter Shockwave Medical, Inc. Peripheral Intravascular Lithotripsy (IVL) System Shockwave S4 IVL Catheter

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
PPN	Percutaneous Catheter, Ultrasound	Cardiovascular	Class 2	870.1250	2024-05-28
PPN	Percutaneous Catheter, Ultrasound	Cardiovascular	Class 2	870.1250	2020-02-06
PPN	Percutaneous Catheter, Ultrasound	Cardiovascular	Class 2	870.1250	2019-09-09
PPN	Percutaneous Catheter, Ultrasound	Cardiovascular	Class 2	870.1250	2024-10-03
PPN	Percutaneous Catheter, Ultrasound	Cardiovascular	Class 2	870.1250	2016-09-23
PPN	Percutaneous Catheter, Ultrasound	Cardiovascular	Class 2	870.1250	2021-05-03
PPN	Percutaneous Catheter, Ultrasound	Cardiovascular	Class 2	870.1250	2022-08-12
OEZ	Cardiovascular Procedure Kit	Cardiovascular	Class 2	870.1200	2021-05-18
PPN	Percutaneous Catheter, Ultrasound	Cardiovascular	Class 2	870.1250	2022-10-10
QMG	Shockwave Intravascular Lithotripsy System	Unknown	Class 3	N/A	2021-02-16
DQY	Catheter, Percutaneous	Cardiovascular	Class 2	870.1250	2025-05-29
PPN	Percutaneous Catheter, Ultrasound	Cardiovascular	Class 2	870.1250	2019-03-20
PPN	Percutaneous Catheter, Ultrasound	Cardiovascular	Class 2	870.1250	2020-02-06

Official Correspondent

Peter Nowakowski

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Shockwave Medical, Inc.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3027545377	SWAV CR SRL	Alajuela, CR

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K043580	Chestnut Medical Technologies, Inc.	ALLIGATOR RETRIEVAL DEVICE (ARD)	2005-03-24
K982883	Medtronics Interventional Vascular	MEDTRONIC 7F AND 8F ZUMA GUIDING CATHETER	1998-09-04
K132420	Reflow Medical	WINGMAN EXTENDABLE TIP SUPPORT CATHETER	2013-09-19
K082339	Endocross, Ltd.	ENABLER-P SUPPORT CATHETER	2008-11-20
K210009	CenterPoint Systems, LLC	Guiding Catheter	2021-11-24

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0001-2010	Penumbra Inc.	2	Penumbra Neuron Delivery Catheter 070, percutaneous catheter, catalog numbers PND6F0701058, PND6F070956, PND6F0701058M, and PND6F070956M; manufactured by Penumbra, Inc., Alameda, CA. Indicated for the introduction of interventional devices into the peripheral, coronary, and neuro vasculature.
Z-0003-2014	Cordis Corporation	2	Cordis ADROIT 6F Guiding Catheter Product Usage: For intravascular introduction of interventional and/or diagnostic devices into the coronary or peripheral vascular system.
Z-0009-2024	Boston Scientific Corporation	2	Guider Softip Guide Catheter 6F PRE-SHAPED 40 90CM, Catalog number H965100420, cardiac guide catheter
Z-0010-04	Bard Peripheral Vascular	2	Conquest Balloon Dilation Catheters Model/Catalog Number CQ 75124
Z-0010-2024	Boston Scientific Corporation	2	Guider Softip Guide Catheter 7F PRE-SHAPED 40 90CM, Catalog number H965100430, cardiac guide catheter

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3015053858. Last updated year: 2026. Please use registration number 3015053858 when referencing this establishment in official correspondence.