Shockwave Medical, Inc.
FDA 510(k) & PMA Approved Devices — 14 products
Total Devices14
Categories3
Latest FDA decision2026-07-27
| Type | Number | Device Name | Code | Date | Actions |
|---|---|---|---|---|---|
| 510(k) | K262201 | Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave E8 Peripheral IVL Catheter | PPN | 2026-07-27 | View |
| PMA | P200039 | Shockwave intravascular lithotripsy system | QMG | 2026-06-29 | View |
| 510(k) | K243757 | Shockwave CS Guide Catheter | DQY | 2025-05-02 | View |
| 510(k) | K242213 | Shockwave Intravascular Lithotripsy (IVL) System with the Javelin Peripheral Intravascular Lithotripsy (IVL) Catheter | PPN | 2024-09-27 | View |
| 510(k) | K240954 | Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave L6 Peripheral IVL Catheter | PPN | 2024-05-07 | View |
| 510(k) | K240225 | Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave E8 Peripheral IVL Catheter | PPN | 2024-03-22 | View |
| 510(k) | K221852 | Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave L6 Peripheral IVL Catheter | PPN | 2022-08-16 | View |
| 510(k) | K221041 | Shockwave Medical Peripheral Intravascular Lithotripsy (IVL) System | PPN | 2022-04-25 | View |
| 510(k) | K203365 | Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave M5+ Peripheral IVL Catheter | PPN | 2021-04-22 | View |
| 510(k) | K191840 | Peripheral Intravascular Lithotripsy (IVL) Catheters, IVL Generator and Connector Cable Kit, IVL Connector Cable (Replacement) | PPN | 2019-08-07 | View |
| 510(k) | K180958 | Shockwave M5 Peripheral Intravascular Lithotripsy (IVL) Catheter, lntravascular Lithotripsy (IVL) Generator And Connector Cable, Intravascular Lithotripsy (IVL) Connector Cable | PPN | 2018-07-26 | View |
| 510(k) | K180454 | Shockwave Medical Intravascular Lithotripsy (IVL) System | PPN | 2018-06-27 | View |
| 510(k) | K163306 | Lithoplasty Peripheral Balloon Dilatation Catheter; Lithoplasty Generator And Connector Cable; Lithoplasty Connector Cable | PPN | 2016-12-22 | View |
| 510(k) | K161384 | Lithoplasty Peripheral Balloon Dilatation Catheter, Lithoplasty Generator and Connector Cable, Lithoplasty Connector Cable | PPN | 2016-09-14 | View |
No matching devices.
Related Clinical Trials
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