510(k) K162896 ยท DTZ Oxygenator, Cardiopulmonary Bypass
Affinity NT Oxygenator, Affinity NT Oxygenator with Trillium Biosurface
| Applicant | Medtronic, Inc., Mounds View MN, US |
| Decision | Substantially Equivalent, Dec 6, 2016 |
| Received | Oct 17, 2016 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K162896
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.