510(k) K233820 ยท DXE Catheter, Embolectomy
Fogarty Arterial Embolectomy Catheter with Gate Valve
| Applicant | Edwards Lifesciences, Irvine CA, US |
| Decision | Substantially Equivalent, May 22, 2024 |
| Received | Dec 1, 2023 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K233820
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.