510(k) K093730 ยท DWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
PORT ACCESS SYSTEMS ENDODIRECT ARTERIAL CANNULA MODEL ED24 (OLD CODE WAS-DFK24)
| Applicant | Edwards Lifesciences, LLC, Midvale UT, US |
| Decision | Substantially Equivalent, Jan 14, 2010 |
| Received | Dec 3, 2009 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K093730
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.