Cleared Traditional

Telescope Guide Extension Catheter

K252390 · Medtronic, Ireland · Cardiovascular
Oct 2025
Decision
90d
Days
Class 2
Risk

About This 510(k) Submission

K252390 is an FDA 510(k) clearance for the Telescope Guide Extension Catheter, a Catheter, Percutaneous (Class II — Special Controls, product code DQY), submitted by Medtronic, Ireland (Galway, IE). The FDA issued a Cleared decision on October 29, 2025, 90 days after receiving the submission on July 31, 2025. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1250.

Submission Details

510(k) Number K252390 FDA.gov
FDA Decision Cleared SESE
Date Received July 31, 2025
Decision Date October 29, 2025
Days to Decision 90 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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