510(k) K221294 ยท MJN Catheter, Intravascular Occluding, Temporary
preCARDIA Occlusion System
| Applicant | Abiomed, Inc., Danvers MA, US |
| Decision | Unknown, Jun 30, 2023 |
| Received | May 4, 2022 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K221294
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.