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FDA 510(k)

GORE® Tri-Lobe Balloon Catheter

K-Number: K250410 · 2025-06-02

ApplicantW. L. Gore & Associates, Inc.
Decision Date2025-06-02
Product CodeDQY
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

GORE® Tri-Lobe Balloon Catheter is a medical device manufactured by W. L. Gore & Associates, Inc.. It received FDA 510(k) clearance on 2025-06-02 under approval number K250410. 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 GORE® Tri-Lobe Balloon Catheter?

GORE® Tri-Lobe Balloon Catheter is a medical device that received FDA 510(k) clearance on 2025-06-02. It is manufactured by W. L. Gore & Associates, Inc.. The 510(k) number is K250410.

When was GORE® Tri-Lobe Balloon Catheter approved by the FDA?

GORE® Tri-Lobe Balloon Catheter received FDA 510(k) clearance on 2025-06-02, under approval number K250410.

What company makes GORE® Tri-Lobe Balloon Catheter?

GORE® Tri-Lobe Balloon Catheter is manufactured by W. L. Gore & Associates, Inc..

What is the FDA product code for GORE® Tri-Lobe Balloon Catheter?

The FDA product code for GORE® Tri-Lobe Balloon Catheter is DQY.

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Other Devices by W. L. Gore & Associates, Inc.

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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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