510(k) K214060 ยท MJN Catheter, Intravascular Occluding, Temporary
LANDMARK REBOA Catheter
| Applicant | Zien Medical Technologies, Inc., Salt Lake City UT, US |
| Decision | Substantially Equivalent, Sep 19, 2022 |
| Received | Dec 27, 2021 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K214060
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.