FDA Product Code
FDA Product Code PPN — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Cardiovascular
- 21 CFR Citation
- 870.1250
510(k) Clearances — 14 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K260246 | SEISMIQ Intravascular Lithotripsy System | Bolt Medical, Inc. | 2026-08-24 | Traditional | PDF ↗ |
| K262201 | Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave E8 Peripheral IVL Catheter | Shockwave Medical, Inc. | 2026-07-27 | Special | PDF ↗ |
| K250225 | Bolt Intravascular Lithotripsy (IVL) System | Bolt Medical, Inc. | 2025-03-25 | Traditional | PDF ↗ |
| K242213 | Shockwave Intravascular Lithotripsy (IVL) System with the Javelin Peripheral Intravascular Lithotripsy (IVL) Catheter | Shockwave Medical, Inc. | 2024-09-27 | Traditional | PDF ↗ |
| K240954 | Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave L6 Peripheral IVL Catheter | Shockwave Medical, Inc. | 2024-05-07 | Special | PDF ↗ |
| K240225 | Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave E8 Peripheral IVL Catheter | Shockwave Medical, Inc. | 2024-03-22 | Traditional | PDF ↗ |
| K221852 | Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave L6 Peripheral IVL Catheter | Shockwave Medical, Inc. | 2022-08-16 | Traditional | PDF ↗ |
| K221041 | Shockwave Medical Peripheral Intravascular Lithotripsy (IVL) System | Shockwave Medical, Inc. | 2022-04-25 | Special | PDF ↗ |
| K203365 | Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave M5+ Peripheral IVL Catheter | Shockwave Medical, Inc. | 2021-04-22 | Traditional | PDF ↗ |
| K191840 | Peripheral Intravascular Lithotripsy (IVL) Catheters, IVL Generator and Connector Cable Kit, IVL Connector Cable (Replacement) | Shockwave Medical, Inc. | 2019-08-07 | Special | PDF ↗ |
| K180958 | Shockwave M5 Peripheral Intravascular Lithotripsy (IVL) Catheter, lntravascular Lithotripsy (IVL) Generator And Connector Cable, Intravascular Lithotripsy (IVL) Connector Cable | Shockwave Medical, Inc. | 2018-07-26 | Traditional | PDF ↗ |
| K180454 | Shockwave Medical Intravascular Lithotripsy (IVL) System | Shockwave Medical, Inc. | 2018-06-27 | Traditional | PDF ↗ |
| K163306 | Lithoplasty Peripheral Balloon Dilatation Catheter; Lithoplasty Generator And Connector Cable; Lithoplasty Connector Cable | Shockwave Medical, Inc. | 2016-12-22 | Special | PDF ↗ |
| K161384 | Lithoplasty Peripheral Balloon Dilatation Catheter, Lithoplasty Generator and Connector Cable, Lithoplasty Connector Cable | Shockwave Medical, Inc. | 2016-09-14 | Traditional | PDF ↗ |
Product code PPN · Class II · Cardiovascular. Data: openFDA.