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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 the device name listed in this FDA 510(k) record. The listed applicant is Bard Peripheral Vascular, Inc.. It received FDA 510(k) clearance on 2025-06-17 under 510(k) 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. The listed applicant is Bard Peripheral Vascular, Inc.. The 510(k) number is K250219.

When did Dorado™ PTA Balloon Dilatation Catheter receive FDA 510(k) clearance?

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

Who is the listed applicant for Dorado™ PTA Balloon Dilatation Catheter?

The FDA 510(k) record lists Bard Peripheral Vascular, Inc. as the applicant. This does not by itself establish the device manufacturer.

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)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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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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