510(k) K203365 ยท PPN Percutaneous Catheter, Ultrasound
Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave M5+ Peripheral IVL Catheter
| Applicant | Shockwave Medical, Inc., Santa Clara CA, US |
| Decision | Substantially Equivalent, Apr 22, 2021 |
| Received | Nov 16, 2020 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K203365
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.