Shockwave Medical, Inc. - FDA 510(k) Cleared Devices
Recent clearances: Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave E8 Peripheral IVL Catheter, Shockwave CS Guide Catheter, Shockwave Intravascular Lithotripsy (IVL) System with the Javelin Peripheral Intravascular Lithotripsy (IVL) Catheter
13
Total
13
Cleared
0
Denied
FDA 510(k) Regulatory Record - Shockwave Medical, Inc. Cardiovascular ✕
13 devices
Cleared
Jul 27, 2026
Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave E8...
Cardiovascular
28d
Cleared
May 02, 2025
Shockwave CS Guide Catheter
Cardiovascular
147d
Cleared
Sep 27, 2024
Shockwave Intravascular Lithotripsy (IVL) System with the Javelin Peripheral...
Cardiovascular
60d
Cleared
May 07, 2024
Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave L6...
Cardiovascular
29d
Cleared
Mar 22, 2024
Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave E8...
Cardiovascular
56d
Cleared
Aug 16, 2022
Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave L6...
Cardiovascular
50d
Cleared
Apr 25, 2022
Shockwave Medical Peripheral Intravascular Lithotripsy (IVL) System
Cardiovascular
17d
Cleared
Apr 22, 2021
Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave M5+...
Cardiovascular
157d
Cleared
Aug 07, 2019
Peripheral Intravascular Lithotripsy (IVL) Catheters, IVL Generator and...
Cardiovascular
29d
Cleared
Jul 26, 2018
Shockwave M5 Peripheral Intravascular Lithotripsy (IVL) Catheter,...
Cardiovascular
105d
Cleared
Jun 27, 2018
Shockwave Medical Intravascular Lithotripsy (IVL) System
Cardiovascular
127d
Cleared
Dec 22, 2016
Lithoplasty Peripheral Balloon Dilatation Catheter
Cardiovascular
29d