510(k) K033464 ยท DWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
EDWARDS LIFESCIENCES RESEARCH MEDICAL PEDIATRIC VENOUS RETURN CANNULAE
| Applicant | Edwards Lifesciences, LLC, Irvine CA, US |
| Decision | Substantially Equivalent, Jun 22, 2004 |
| Received | Oct 31, 2003 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K033464
| 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.