510(k) K183490 ยท DTZ Oxygenator, Cardiopulmonary Bypass
Affinity NT Oxygenator, Affinity NT Oxygenator with Trillium Biosurface, Affinity NT Oxygenator with Cortiva BioActive Surface, Affinity Fusion Oxygenator with Cortiva BioActive Surface, Affinity Fusion Oxygenator with Balance Biosurface
| Applicant | Medtronic, Inc., Minneapolis MN, US |
| Decision | Substantially Equivalent, Apr 12, 2019 |
| Received | Dec 17, 2018 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K183490
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.