510(k) K200358 ยท DWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
Fem-Flex II Femoral Arterial Cannula, Fem-Flex II Femoral Venous Cannula, Femoral Venous Cannula, FemTrak Femoral Venous Cannula
| Applicant | Edwards Lifesciences, LLC, Irvine CA, US |
| Decision | Substantially Equivalent, Mar 13, 2020 |
| Received | Feb 13, 2020 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K200358
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.