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FDA 510(k)

Dorado™ PTA Balloon Dilatation Catheter

K-Number: K250219 · 2025-06-17

ApplicantBard Peripheral Vascular, Inc.
Decision Date2025-06-17
Product CodeDQY
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Dorado™ PTA Balloon Dilatation Catheter is a medical device manufactured by Bard Peripheral Vascular, Inc.. It received FDA 510(k) clearance on 2025-06-17 under approval number K250219. The device is classified under product code DQY. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Dorado™ PTA Balloon Dilatation Catheter?

Dorado™ PTA Balloon Dilatation Catheter is a medical device that received FDA 510(k) clearance on 2025-06-17. It is manufactured by Bard Peripheral Vascular, Inc.. The 510(k) number is K250219.

When was Dorado™ PTA Balloon Dilatation Catheter approved by the FDA?

Dorado™ PTA Balloon Dilatation Catheter received FDA 510(k) clearance on 2025-06-17, under approval number K250219.

What company makes Dorado™ PTA Balloon Dilatation Catheter?

Dorado™ PTA Balloon Dilatation Catheter is manufactured by Bard Peripheral Vascular, Inc..

What is the FDA product code for Dorado™ PTA Balloon Dilatation Catheter?

The FDA product code for Dorado™ PTA Balloon Dilatation Catheter is DQY.

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Related Devices (Code: DQY)

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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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