510(k) K001565 ยท DWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
STEERABLE RETROGRADE CARDIOPLEGIA CANNULA WITH AND WITHOUT DURAFLO TREATMENT, MODELS SRCO14MIB, DIISRCO14MIB
| Applicant | Edwards Lifesciences, LLC, Midvale UT, US |
| Decision | Substantially Equivalent, Aug 10, 2000 |
| Received | May 19, 2000 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K001565
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.