510(k) K260012 · PNO Catheter, Percutaneous, Cutting/Scoring
UltraScore Focused Force PTA Balloon
| Applicant | Bard Peripheral Vascular, Inc., Tempe AZ, US |
| Decision | Substantially Equivalent, Feb 4, 2026 |
| Received | Jan 5, 2026 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K260012
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.