510(k) K243795 ยท MJN Catheter, Intravascular Occluding, Temporary
pREBOA-PRO Catheter
| Applicant | Prytime Medical Devices, Inc., Boerne TX, US |
| Decision | Substantially Equivalent, Sep 5, 2025 |
| Received | Dec 10, 2024 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K243795
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.