510(k) K152762 ยท MJN Catheter, Intravascular Occluding, Temporary
Fogarty Occlusion Catheter
| Applicant | Edwards Lifesciences, LLC, Irvine CA, US |
| Decision | Substantially Equivalent, Nov 23, 2015 |
| Received | Sep 24, 2015 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K152762
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.