510(k) K143073 ยท DTZ Oxygenator, Cardiopulmonary Bypass
Affinity NT Oxygenator, Affinity NT Oxygenator with Trillium Biosurface, Affinity NT Oxygenator with Carmeda Biosurface
| Applicant | Medtronic, Inc., Minneapolis MN, US |
| Decision | Substantially Equivalent, Mar 25, 2015 |
| Received | Oct 27, 2014 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K143073
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.