510(k) K122827 ยท DTZ Oxygenator, Cardiopulmonary Bypass
AFFINITY FUSION OXYGENATOR WITH INTEGRATED ARTERIAL FILTER AND BALANCE BIOSURFACE MODEL BB811
| Applicant | Medtronic, Inc., Minneapolis MN, US |
| Decision | Substantially Equivalent, Dec 14, 2012 |
| Received | Sep 14, 2012 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K122827
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.