510(k) K262013 ยท PDU Catheter For Crossing Total Occlusions
Kiba CTO Crossing Catheter
| Applicant | Reflow Medical, Inc., San Clemente CA, US |
| Decision | Substantially Equivalent, Aug 28, 2026 |
| Received | Jun 15, 2026 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K262013
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.