Cleared Traditional

GORE? Tri-Lobe Balloon Catheter

K250410 · W.L. Gore & Associates, Inc. · Cardiovascular
Jun 2025
Decision
109d
Days
Class 2
Risk

About This 510(k) Submission

K250410 is an FDA 510(k) clearance for the GORE? Tri-Lobe Balloon Catheter, a Catheter, Percutaneous (Class II — Special Controls, product code DQY), submitted by W.L. Gore & Associates, Inc. (Phoenix, US). The FDA issued a Cleared decision on June 2, 2025, 109 days after receiving the submission on February 13, 2025. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1250.

Submission Details

510(k) Number K250410 FDA.gov
FDA Decision Cleared SESE
Date Received February 13, 2025
Decision Date June 02, 2025
Days to Decision 109 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF

Device Classification

Product Code DQY — Catheter, Percutaneous
Device Class Class II — Special Controls
CFR Regulation 21 CFR 870.1250

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