510(k) K033463 ยท DWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
EDWARDS LIFESCIENCES RESEARCH MEDICAL PEDIATRIC ARTERIAL CANNULAE
| Applicant | Edwards Lifesciences, LLC, Irvine CA, US |
| Decision | Substantially Equivalent, Jul 28, 2004 |
| Received | Oct 31, 2003 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K033463
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 13, 2011 | Edwards Lifesciences Llc Edwards Aortic Perfusion Cannula with Duraflow Coating, REF: DARH201190TA, 20 Fr. x 28 cm, Sterile EO, Edwards Lifesciences LLC, Irvine, CA 92614.
The cannula perfuses blood to the ascending aorta du Terminated |
DWF | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.