Company ยท US
Shockwave Medical, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 2016 to 2026. Name variants (Inc, Corp, punctuation) are merged.
13510(k) clearances (1 in 12 months)
1recalls (0 in 12 months)
1recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jul 27, 2026 | K262201 | Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave E8 Peripheral IVL Catheter Shockwave Medical, Inc. | PPN |
| May 2, 2025 | K243757 | Shockwave CS Guide Catheter Shockwave Medical, Inc. | DQY |
| Sep 27, 2024 | K242213 | Shockwave Intravascular Lithotripsy (IVL) System with the Javelin Peripheral Intravascular Lithotripsy (IVL) Catheter Shockwave Medical, Inc. | PPN |
| May 7, 2024 | K240954 | Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave L6 Peripheral IVL Catheter Shockwave Medical, Inc. | PPN |
| Mar 22, 2024 | K240225 | Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave E8 Peripheral IVL Catheter Shockwave Medical, Inc. | PPN |
| Aug 16, 2022 | K221852 | Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave L6 Peripheral IVL Catheter Shockwave Medical, Inc. | PPN |
| Apr 25, 2022 | K221041 | Shockwave Medical Peripheral Intravascular Lithotripsy (IVL) System Shockwave Medical, Inc. | PPN |
| Apr 22, 2021 | K203365 | Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave M5+ Peripheral IVL Catheter Shockwave Medical, Inc. | PPN |
| Aug 7, 2019 | K191840 | Peripheral Intravascular Lithotripsy (IVL) Catheters, IVL Generator and Connector Cable Kit, IVL Connector Cable (Replac Shockwave Medical, Inc. | PPN |
| Jul 26, 2018 | K180958 | Shockwave M5 Peripheral Intravascular Lithotripsy (IVL) Catheter, lntravascular Lithotripsy (IVL) Generator And Connecto Shockwave Medical, Inc. | PPN |
| Jun 27, 2018 | K180454 | Shockwave Medical Intravascular Lithotripsy (IVL) System Shockwave Medical, Inc. | PPN |
| Dec 22, 2016 | K163306 | Lithoplasty Peripheral Balloon Dilatation Catheter; Lithoplasty Generator And Connector Cable; Lithoplasty Connector Cab Shockwave Medical, Inc. | PPN |
| Sep 14, 2016 | K161384 | Lithoplasty Peripheral Balloon Dilatation Catheter, Lithoplasty Generator and Connector Cable, Lithoplasty Connector Cab Shockwave Medical, Inc. | PPN |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 18, 2018 | Shockwave Medical, Inc. The Shockwave S4 IVL Catheters are intended for lithotripsy-enhanced balloon dilatation of lesions, including calcified lesions, in the peripheral vasculature, including the iliac, femoral, ilio-femor Terminated |
PPN | K180454 |