510(k) K251158 · PDU Catheter For Crossing Total Occlusions
PowerWire® 14 Radiofrequency Guidewire Kit
| Applicant | Baylis Medical Technologies, Inc., Mississauga, CA |
| Decision | Unknown, Sep 11, 2025 |
| Received | Apr 15, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K251158
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.