510(k) K240225 ยท PPN Percutaneous Catheter, Ultrasound
Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave E8 Peripheral IVL Catheter
| Applicant | Shockwave Medical, Inc., Santa Clara CA, US |
| Decision | Substantially Equivalent, Mar 22, 2024 |
| Received | Jan 26, 2024 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K240225
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.