510(k) K891576 ยท DWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
FEM-FLEX FEMORAL ACCESS CANNULATION SET
| Applicant | Research Medical, Inc., Salt Lake City UT, US |
| Decision | Substantially Equivalent, Oct 12, 1989 |
| Received | Mar 20, 1989 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K891576
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 11, 2008 | Edwards Lifesciences Research Medical, Inc. Edwards Lifesciences LLC, Fem-Flex II Femoral Venous Cannula, 12 Fr. x 11.5 cm, REF FEMII012V, Cardiopulmonary bypass tubing. Terminated |
DWF | None listed |
| Sep 11, 2008 | Edwards Lifesciences Research Medical, Inc. Edwards Lifesciences LLC, Fem-Flex II Duraflo Treated Femoral Venous Catheter, 8 Fr. x 11.5 cm, REF DIIFEMII008V, Cardiopulmonary bypass tubing. Terminated |
DWF | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.