510(k) K223161 ยท DTZ Oxygenator, Cardiopulmonary Bypass
OXY-1 System
| Applicant | Abiomed, Inc., Danvers MA, US |
| Decision | Substantially Equivalent, Feb 23, 2023 |
| Received | Oct 7, 2022 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K223161
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.