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Shockwave Medical, Inc.

24 FDA 510(k) clearances · PMA applicant

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RecordFirmDate
Shockwave™ lntravascular Lithotripsy {IVL) System with Shockwave C2/ C2+/ C2 Aero Coronary IVL Catheter (P200039/S018)Shockwave Medical, Inc.2025-10-14
Shockwave Intravascular Lithotripsy (IVL) 825 Series Generators (P200039/S017)Shockwave Medical, Inc.2025-06-27
Shockwave Intravascular Lithotripsy (IVL) System with Shockwave C2 Aero Coronary Intravascular Lithotripsy (IVL) Cathete (P200039/S015)Shockwave Medical, Inc.2025-06-10
Shockwave Intravascular Lithotripsy (IVL) System with Shockwave C2 Coronary Intravascular Lithotripsy (IVL) Catheter (P200039/S016)Shockwave Medical, Inc.2025-05-30
Shockwave Intravascular System with the C2/C2+ Coronary IVL Catheter (P200039/S013)Shockwave Medical, Inc.2024-10-24
Shockwave C2/C2+ Intravascular Lithotripsy (IVL) Catheter (P200039/S014)Shockwave Medical, Inc.2024-03-26
Shockwave Intravascular Lithotripsy (IVL) System with Shockwave C2 Coronary Intravascular Lithotripsy (IVL) Catheter (P200039/S005)Shockwave Medical, Inc.2023-08-17
Shockwave C2/C2+ Intravascular Lithotripsy (IVL) Catheter, IVL Generator and Connector Cable Kit, IVL Connector Cable (r (P200039/S012)Shockwave Medical, Inc.2023-06-15
Shockwave Intravascular Lithotripsy (IVL) System with Shockwave C2 Coronary Intravascular Lithotripsy (IVL) Catheter (P200039/S011)Shockwave Medical, Inc.2023-05-08
Shockwave Intravascular Lithotripsy (IVL) System (Shockwave IVL System) with Shockwave C2 and C2+ IVL Catheters (P200039/S010)Shockwave Medical, Inc.2023-03-22
Shockwave C2 Intravascular Lithotripsy (IVL) Catheter, VL Generator and Connector Cable Kit, IVL Connector Cable (Replac (P200039/S009)Shockwave Medical, Inc.2023-02-02
Shockwave Intravascular Lithotripsy (IVL) System with Shockwave C2+ Coronary Intravascular Lithotripsy (IVL) Catheter (P200039/S008)Shockwave Medical, Inc.2022-12-13
Shockwave Intravascular Lithotripsy (IVL) Generator, Shockwave Intravascular Lithotripsy (IVL) System with Shockwave C2 (P200039/S007)Shockwave Medical, Inc.2022-09-01
Shockwave Medical, Inc. IVL Generator and Connector Cable Kit, Shockwave C2 Coronary IVL Catheter (P200039/S006)Shockwave Medical, Inc.2022-03-23
Shockwave C2 Intravascular (IVL) Catheter, IVL Generator and Connector Cable Kit, IVL Connector Cable (Replacement) (P200039/S004)Shockwave Medical, Inc.2022-01-04
Shockwave Intravascular Lithotripsy (IVL) System with Shockwave C2 IVL Catheter (P200039/S003)Shockwave Medical, Inc.2021-07-22
Shockwave Intravascular Lithotripsy (IVL) System with Shockwave C2 Coronary Intravascular Lithotripsy (IVL) Catheter (P200039/S002)Shockwave Medical, Inc.2021-06-04
Shockwave Intravascular Lithotripsy (IVL) System with Shockwave C2 Coronary Intravascular Lithotripsy (IVL) Catheter (P200039/S001)Shockwave Medical, Inc.2021-04-09
Shockwave Intravascular Lithotripsy (IVL) System with Shockwave C2 Coronary Intravascular Lithotripsy (IVL) Catheter (P200039)Shockwave Medical, Inc.2021-02-12

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