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Shockwave Medical, Inc.

13 FDA 510(k) clearances · Manufacturer

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RecordFirmDate
Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave E8 Peripheral IVL Catheter (K262201)Shockwave Medical, Inc.2026-07-27
Shockwave CS Guide Catheter (K243757)Shockwave Medical, Inc.2025-05-02
Shockwave Intravascular Lithotripsy (IVL) System with the Javelin Peripheral Intravascular Lithotripsy (IVL) Catheter (K242213)Shockwave Medical, Inc.2024-09-27
Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave L6 Peripheral IVL Catheter (K240954)Shockwave Medical, Inc.2024-05-07
Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave E8 Peripheral IVL Catheter (K240225)Shockwave Medical, Inc.2024-03-22
Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave L6 Peripheral IVL Catheter (K221852)Shockwave Medical, Inc.2022-08-16
Shockwave Medical Peripheral Intravascular Lithotripsy (IVL) System (K221041)Shockwave Medical, Inc.2022-04-25
Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave M5+ Peripheral IVL Catheter (K203365)Shockwave Medical, Inc.2021-04-22
Peripheral Intravascular Lithotripsy (IVL) Catheters, IVL Generator and Connector Cable Kit, IVL Connector Cable (Replacement) (K191840)Shockwave Medical, Inc.2019-08-07
Shockwave M5 Peripheral Intravascular Lithotripsy (IVL) Catheter, lntravascular Lithotripsy (IVL) Generator And Connector Cable, Intravascular Lithotripsy (IVL) Connector Cable (K180958)Shockwave Medical, Inc.2018-07-26
Shockwave Medical Intravascular Lithotripsy (IVL) System (K180454)Shockwave Medical, Inc.2018-06-27
Lithoplasty Peripheral Balloon Dilatation Catheter; Lithoplasty Generator And Connector Cable; Lithoplasty Connector Cable (K163306)Shockwave Medical, Inc.2016-12-22
Lithoplasty Peripheral Balloon Dilatation Catheter, Lithoplasty Generator and Connector Cable, Lithoplasty Connector Cable (K161384)Shockwave Medical, Inc.2016-09-14

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Every clearance here is in the API, with alerts when new ones post.