510(k) K991170 ยท DWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
RETROGRADE CARDIOPLEGIA CANNULA WITH DURAFLO TREATMENT, MODEL DII-RC-014
| Applicant | Edwards Lifesciences Research Medical, Midvale UT, US |
| Decision | Substantially Equivalent, Jul 2, 1999 |
| Received | Apr 7, 1999 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K991170
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.