Submission Details
| 510(k) Number | K260012 FDA.gov |
| FDA Decision | Cleared 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 |
Cleared
Special
UltraScore? Focused Force PTA Balloon
Feb 2026
Decision
30d
Days
Class 2
Risk
About This 510(k) Submission
K260012 is an FDA 510(k) clearance for the UltraScore? Focused Force PTA Balloon, 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 review panel. Regulated under 21 CFR 870.1250.
Device Classification
| 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 |
Manufacturer
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