FDA 510(k) Applications Submitted by Shockwave Medical, Inc.
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K240225 |
01/26/2024 |
Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave E8 Peripheral IVL Catheter |
Shockwave Medical, Inc. |
| K240954 |
04/08/2024 |
Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave L6 Peripheral IVL Catheter |
Shockwave Medical, Inc. |
| K180958 |
04/12/2018 |
Shockwave M5 Peripheral Intravascular Lithotripsy (IVL) Catheter, lntravascular Lithotripsy (IVL) Generator And Connector Cable, Intravascular Lithotripsy (IVL) Connector Cable |
Shockwave Medical, Inc. |
| K191840 |
07/09/2019 |
Peripheral Intravascular Lithotripsy (IVL) Catheters, IVL Generator and Connector Cable Kit, IVL Connector Cable (Replacement) |
Shockwave Medical, Inc. |
| K221852 |
06/27/2022 |
Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave L6 Peripheral IVL Catheter |
Shockwave Medical, Inc. |
| K203365 |
11/16/2020 |
Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave M5+ Peripheral IVL Catheter |
Shockwave Medical, Inc. |
| K161384 |
05/19/2016 |
Lithoplasty Peripheral Balloon Dilatation Catheter, Lithoplasty Generator and Connector Cable, Lithoplasty Connector Cable |
Shockwave Medical, Inc. |
| K180454 |
02/20/2018 |
Shockwave Medical Intravascular Lithotripsy (IVL) System |
Shockwave Medical, Inc. |
| K163306 |
11/23/2016 |
Lithoplasty Peripheral Balloon Dilatation Catheter; Lithoplasty Generator And Connector Cable; Lithoplasty Connector Cable |
Shockwave Medical, Inc. |
| K243757 |
12/06/2024 |
Shockwave CS Guide Catheter |
Shockwave Medical, Inc. |
| K242213 |
07/29/2024 |
Shockwave Intravascular Lithotripsy (IVL) System with the Javelin Peripheral Intravascular Lithotripsy (IVL) Catheter |
Shockwave Medical, Inc. |
| K221041 |
04/08/2022 |
Shockwave Medical Peripheral Intravascular Lithotripsy (IVL) System |
Shockwave Medical, Inc. |
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