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FDA 510(k)

UltraScore™ Focused Force PTA Balloon

K-Number: K260012 · 2026-02-04

ApplicantBard Peripheral Vascular, Inc.
Decision Date2026-02-04
Product CodePNO
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

UltraScore™ Focused Force PTA Balloon is a medical device manufactured by Bard Peripheral Vascular, Inc.. It received FDA 510(k) clearance on 2026-02-04 under approval number K260012. The device is classified under product code PNO. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the UltraScore™ Focused Force PTA Balloon?

UltraScore™ Focused Force PTA Balloon is a medical device that received FDA 510(k) clearance on 2026-02-04. It is manufactured by Bard Peripheral Vascular, Inc.. The 510(k) number is K260012.

When was UltraScore™ Focused Force PTA Balloon approved by the FDA?

UltraScore™ Focused Force PTA Balloon received FDA 510(k) clearance on 2026-02-04, under approval number K260012.

What company makes UltraScore™ Focused Force PTA Balloon?

UltraScore™ Focused Force PTA Balloon is manufactured by Bard Peripheral Vascular, Inc..

What is the FDA product code for UltraScore™ Focused Force PTA Balloon?

The FDA product code for UltraScore™ Focused Force PTA Balloon is PNO.

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Related Devices (Code: PNO)

K152789FLEX SCORING CATHETERVenturemed Group K172571ULTRASCORE Focused Force PTA BalloonC. R. Bard K163420UltraScore Focused Force PTA BalloonBard Peripheral Vascular, Inc. K163380Serranator Alto PTA Serration Balloon CatheterCagent Vascular, LLC K182713Scoreflex PTA Scoring Balloon CatheterOrbusneich Medical Trading, Inc. K203437Serranator PTA Serration Balloon CatheterCagent Vascular, LLC

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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