510(k) K113459 ยท DWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
ANTEPLEGIA CATHETER ANTEGRADE CARDIOPLEGIA CATHETER AORTIC ROOT CANNULA ANTEGRADE CATHETER WITH DURAFLO COATING
| Applicant | Edwards Lifesciences, LLC, Draper UT, US |
| Decision | Substantially Equivalent, Jun 29, 2012 |
| Received | Nov 22, 2011 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K113459
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.