510(k) K192786 ยท MJN Catheter, Intravascular Occluding, Temporary
Gatekeeper Balloon Catheter
| Applicant | Arch Catheter, LLC, Ninety Six SC, US |
| Decision | Substantially Equivalent, Apr 25, 2020 |
| Received | Sep 30, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K192786
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.