510(k) K252315 · PDU Catheter For Crossing Total Occlusions
Santreva-ATK Endovascular Revasculariztion Catheter
| Applicant | AngioSafe, Inc., San Jose CA, US |
| Decision | Substantially Equivalent, Sep 22, 2025 |
| Received | Jul 25, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K252315
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.