UltraScore Focused Force PTA Balloon— 510(k) K260012
Substantially EquivalentBard Peripheral Vascular, Inc.
FDA 510(k) clearance K260012 for UltraScore Focused Force PTA Balloon, Substantially Equivalent on 2026-02-04. Applicant: Bard Peripheral Vascular, Inc.. Device class: 2.
Summary
Bard Peripheral Vascular's UltraScore Focused Force PTA Balloon is filed under product code PNO (Catheter, Percutaneous, Cutting/Scoring). The record doesn't describe the balloon beyond its name and that code name.
Class II, 21 CFR 870.1250. Cardiovascular is both the classification panel and the review panel, and it came in as a Special 510(k).
Bard Peripheral Vascular filed from Tempe, Arizona. The decision came 30 calendar days after FDA received it (January 5 to February 4, 2026), and it was substantially equivalent.
Clearance details
- Applicant
- Bard Peripheral Vascular, Inc.
- Product code
- Product code PNO
- Device class
- Class 2
- Regulation
- 21 CFR 870.1250
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Tempe, AZ, US
Recent devices under product code PNO
view all- K260686 — Zylox PanFlex Percutaneous Transluminal Angioplasty Scoring Catheter
- K261778 — JADE SCORE PTA Scoring Balloon Dilatation Catheter
- K243944 — Aperta NSE PTA Balloon Dilatation Catheter
- K242254 — D·Kutting LL Peripheral Scoring Balloon Dilatation Catheter
- K241478 — Tri-Wedge PTA Scoring Balloon Dilatation Catheter
More clearances from Bard Peripheral Vascular, Inc.
view allAdverse events under product code PNO
product code PNO- Malfunction
- 1,646
- Total
- 1,646
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.