K260012 is an FDA 510(k) clearance for the UltraScore™ Focused Force PTA Balloon. This device is classified as a Catheter, Percutaneous, Cutting/scoring (Class II - Special Controls, product code PNO).
Submitted by Bard Peripheral Vascular, Inc. (Tempe, US). The FDA issued a Cleared decision on February 4, 2026, 30 days after receiving the submission on January 5, 2026.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.1250. To Reduce Vascular Stenosis By Dilatation And Apposition Of The Cutting/scoring Surfaces To The Stenotic Material.
| 510(k) Number | K260012 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 05, 2026 |
| Decision Date | February 04, 2026 |
| Days to Decision | 30 days |
| Submission Type | Special |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | PNO — Catheter, Percutaneous, Cutting/scoring |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.1250 |
| Definition | To Reduce Vascular Stenosis By Dilatation And Apposition Of The Cutting/scoring Surfaces To The Stenotic Material |