Shockwave Medical, Inc.
FDA Regulatory Profile
Shockwave Medical, Inc. appears in FDA public data with 1 recall, 13 510(k) clearances, 2 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-3247-2018, Class II) was initiated on Jul 18, 2018. Its most recent 510(k) clearance was granted on Jul 27, 2026.
Summary
- Total Recalls
- 1
- 510(k) Clearances
- 13
- Inspections
- 2
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-3247-2018 | Class II | The Shockwave S4 IVL Catheters are intended for lithotripsy-enhanced balloon dilatation of lesions, | Jul 18, 2018 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K262201 | Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave E8 Peripheral IVL Catheter | Jul 27, 2026 |
| K243757 | Shockwave CS Guide Catheter | May 2, 2025 |
| K242213 | Shockwave Intravascular Lithotripsy (IVL) System with the Javelin Peripheral Intravascular Lithotrip | Sep 27, 2024 |
| K240954 | Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave L6 Peripheral IVL Catheter | May 7, 2024 |
| K240225 | Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave E8 Peripheral IVL Catheter | Mar 22, 2024 |
| K221852 | Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave L6 Peripheral IVL Catheter | Aug 16, 2022 |
| K221041 | Shockwave Medical Peripheral Intravascular Lithotripsy (IVL) System | Apr 25, 2022 |
| K203365 | Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave M5+ Peripheral IVL Catheter | Apr 22, 2021 |
| K191840 | Peripheral Intravascular Lithotripsy (IVL) Catheters, IVL Generator and Connector Cable Kit, IVL Con | Aug 7, 2019 |
| K180958 | Shockwave M5 Peripheral Intravascular Lithotripsy (IVL) Catheter, lntravascular Lithotripsy (IVL) Ge | Jul 26, 2018 |
| K180454 | Shockwave Medical Intravascular Lithotripsy (IVL) System | Jun 27, 2018 |
| K163306 | Lithoplasty Peripheral Balloon Dilatation Catheter; Lithoplasty Generator And Connector Cable; Litho | Dec 22, 2016 |
| K161384 | Lithoplasty Peripheral Balloon Dilatation Catheter, Lithoplasty Generator and Connector Cable, Litho | Sep 14, 2016 |