510(k) K211610 ยท MJN Catheter, Intravascular Occluding, Temporary
Fogarty Occlusion Catheter
| Applicant | Edwards Lifesciences, LLC, Irvine CA, US |
| Decision | Substantially Equivalent, Feb 14, 2022 |
| Received | May 25, 2021 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K211610
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.