K260012
- 510(k) number
- K260012
- Device name
- UltraScore Focused Force PTA Balloon
- Applicant
- Bard Peripheral Vascular, Inc. AZ · US
- Product code
- PNO — Catheter, Percutaneous, Cutting/Scoring
- Decision date
- 2026-02-04
- Date received
- 2026-01-05
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- Cardiovascular
PDFDownload 510(k) SummaryArchived here · 2.5 MB · U.S. public domain
Also available from FDA: K260012.pdf
Official FDA record: K260012
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.