510(k) K240078 ยท DXE Catheter, Embolectomy
Fogarty Thru-Lumen Embolectomy Catheter
| Applicant | Edwards Lifesciences, LLC, Irvine CA, US |
| Decision | Substantially Equivalent, Aug 28, 2024 |
| Received | Jan 11, 2024 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K240078
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.