510(k) K232767 ยท BYS Oxygenator, Long Term Support Greater Than 6 Hours
Nautilus VF ECMO Oxygenator
| Applicant | Mc3, Inc., Dexter MI, US |
| Decision | Substantially Equivalent, Oct 4, 2023 |
| Received | Sep 11, 2023 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K232767
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.