FDA 510(k)

GORE® Tri-Lobe Balloon Catheter

K-Number: K250410 · 2025-06-02

Decision Date2025-06-02

Product CodeDQY

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

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.

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. 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.

Related Clinical Trials

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.

NCT05811364The GORE VBX FORWARD Clinical Study: A Comparison of the GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis to Bare Metal Stenting for Patients With Complex Iliac Occlusive DiseaseRECRUITING NCT06872905Real-World Data Collection of the GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis When Used in Covered Endovascular Reconstruction of the Aortic Bifurcation (CERAB) to Treat Aortoiliac Occlusive DiseaseRECRUITING NCT07279649GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis Post-Market Clinical Follow-Up (PMCF) Observational Registry (RE-PROVE)RECRUITING NCT02380716ARISE: Evaluation of the GORE® Ascending Stent Graft in the Treatment of DeBakey Type I/II Aortic DissectionCOMPLETED NCT03728985Evaluation of the GORE® EXCLUDER® Thoracoabdominal Branch Endoprosthesis in the Treatment of Thoracoabdominal and Pararenal Aortic AneurysmsACTIVE_NOT_RECRUITING NCT03821129GORE® CARDIOFORM Septal Occluder and Antiplatelet Medical Management for Reduction of Recurrent Stroke in Patients With Patent Foramen Ovale (PFO): the REDUCE Post Approval StudyRECRUITING

Other records listing W. L. Gore & Associates, Inc. as applicant

PMA P050006Transcatheter septal occluder PMA P210032SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT PMA P020004SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT PMA P230023Endovascular system for treatment of thoracoabdominal and pararenal aortic lesions PMA P160021Iliac covered stent, arterial PMA P130006System, endovascular graft, arteriovenous (AV) dialysis access circuit stenosis treatment

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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.