510(k) K230640 · DTZ Oxygenator, Cardiopulmonary Bypass
Affinity Fusion Oxygenator System
| Applicant | Medtronic, Inc., Minneapolis MN, US |
| Decision | Substantially Equivalent, Apr 6, 2023 |
| Received | Mar 8, 2023 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K230640
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.