FDA 510(k)

GORE® Tri-Lobe Balloon Catheter

Número K: K250410 · 2025-06-02

Data da decisão2025-06-02

Código do produtoDQY

Comité consultivoCV

DecisãoSubstantially Equivalent

Resumo do dispositivo

GORE® Tri-Lobe Balloon Catheter is the device name listed in this FDA 510(k) record. The listed applicant is W. L. Gore & Associates, Inc.. It received FDA 510(k) clearance on 2025-06-02 under 510(k) number K250410. The device is classified under product code DQY. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

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. The listed applicant is W. L. Gore & Associates, Inc.. The 510(k) number is K250410.

When did GORE® Tri-Lobe Balloon Catheter receive FDA 510(k) clearance?

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

Who is the listed applicant for GORE® Tri-Lobe Balloon Catheter?

The FDA 510(k) record lists W. L. Gore & Associates, Inc. as the applicant. This does not by itself establish the device manufacturer.

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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Fonte oficial

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