Medical Device Manufacturer · US , Fremont , CA

Shockwave Medical, Inc. - FDA 510(k) Cleared Devices

12 submissions · 12 cleared · Since 2016
12
Total
12
Cleared
0
Denied

Shockwave Medical, Inc. has 12 FDA 510(k) cleared cardiovascular devices. Based in Fremont, US.

Latest FDA clearance: May 2025. Active since 2016.

Browse the complete list of FDA 510(k) cleared cardiovascular devices from this manufacturer. Filter by specialty or product code using the sidebar.

FDA 510(k) cleared devices by Shockwave Medical, Inc.

12 devices
1-12 of 12
Cleared May 02, 2025
Shockwave CS Guide Catheter
K243757 · DQY
Cardiovascular · 147d
Cleared Sep 27, 2024
Shockwave Intravascular Lithotripsy (IVL) System with the Javelin Peripheral...
K242213 · PPN
Cardiovascular · 60d
Cleared May 07, 2024
Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave L6...
K240954 · PPN
Cardiovascular · 29d
Cleared Mar 22, 2024
Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave E8...
K240225 · PPN
Cardiovascular · 56d
Cleared Aug 16, 2022
Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave L6...
K221852 · PPN
Cardiovascular · 50d
Cleared Apr 25, 2022
Shockwave Medical Peripheral Intravascular Lithotripsy (IVL) System
K221041 · PPN
Cardiovascular · 17d
Cleared Apr 22, 2021
Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave M5+...
K203365 · PPN
Cardiovascular · 157d
Cleared Aug 07, 2019
Peripheral Intravascular Lithotripsy (IVL) Catheters, IVL Generator and...
K191840 · PPN
Cardiovascular · 29d
Cleared Jul 26, 2018
Shockwave M5 Peripheral Intravascular Lithotripsy (IVL) Catheter,...
K180958 · PPN
Cardiovascular · 105d
Cleared Jun 27, 2018
Shockwave Medical Intravascular Lithotripsy (IVL) System
K180454 · PPN
Cardiovascular · 127d
Cleared Dec 22, 2016
Lithoplasty Peripheral Balloon Dilatation Catheter
K163306 · PPN
Cardiovascular · 29d
Cleared Sep 14, 2016
Lithoplasty Peripheral Balloon Dilatation Catheter, Lithoplasty Generator and...
K161384 · PPN
Cardiovascular · 118d
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