Cleared Traditional

SureAx-Guide?

K250203 · Sureax Medical, LLC · Cardiovascular
Oct 2025
Decision
266d
Days
Class 2
Risk

About This 510(k) Submission

K250203 is an FDA 510(k) clearance for the SureAx-Guide?, a Wire, Guide, Catheter (Class II — Special Controls, product code DQX), submitted by Sureax Medical, LLC (San Diego, US). The FDA issued a Cleared decision on October 17, 2025, 266 days after receiving the submission on January 24, 2025. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1330.

Submission Details

510(k) Number K250203 FDA.gov
FDA Decision Cleared SESE
Date Received January 24, 2025
Decision Date October 17, 2025
Days to Decision 266 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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