510(k) K160598 ยท MJN Catheter, Intravascular Occluding, Temporary
REBOA Balloon Catheter
| Applicant | NuMED, Inc., Hopkinton NY, US |
| Decision | Substantially Equivalent, Jun 20, 2016 |
| Received | Mar 2, 2016 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K160598
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.