Cleared Traditional

Medtronic Stedi Extra Support Guidewire

K250075 · Medtronic, Inc. · Cardiovascular
Jun 2025
Decision
154d
Days
Class 2
Risk

About This 510(k) Submission

K250075 is an FDA 510(k) clearance for the Medtronic Stedi Extra Support Guidewire, a Wire, Guide, Catheter (Class II — Special Controls, product code DQX), submitted by Medtronic, Inc. (Minneapolis,, US). The FDA issued a Cleared decision on June 13, 2025, 154 days after receiving the submission on January 10, 2025. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1330.

Submission Details

510(k) Number K250075 FDA.gov
FDA Decision Cleared SESE
Date Received January 10, 2025
Decision Date June 13, 2025
Days to Decision 154 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF

Device Classification

Product Code DQX — Wire, Guide, Catheter
Device Class Class II — Special Controls
CFR Regulation 21 CFR 870.1330

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