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FDA 510(k)

UltraScore Focused Force PTA Balloon

K-Number: K163420 · 2017-06-14

ApplicantBard Peripheral Vascular, Inc.
Decision Date2017-06-14
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 2017-06-14 under approval number K163420. 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 2017-06-14. It is manufactured by Bard Peripheral Vascular, Inc.. The 510(k) number is K163420.

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

UltraScore Focused Force PTA Balloon received FDA 510(k) clearance on 2017-06-14, under approval number K163420.

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)

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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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