510(k) K183679 ยท MJN Catheter, Intravascular Occluding, Temporary
Occlusion Balloon Catheter
| Applicant | Qxmedical, LLC, Saint Paul MN, US |
| Decision | Substantially Equivalent, Apr 24, 2019 |
| Received | Dec 28, 2018 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K183679
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.