510(k) K974259 ยท DWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
VENOUS FLEX II PERIPHERAL AND INTRA-OPERATIVE ACCESS VENOUS RETURN CANNULAE
| Applicant | Edwards Lifesciences Research Medical, Midvale UT, US |
| Decision | Substantially Equivalent, Dec 1, 1998 |
| Received | Nov 13, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K974259
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.