Cleared Traditional

Amplatzer Guidewire

K250031 · Abbott Medical · Cardiovascular
Oct 2025
Decision
269d
Days
Class 2
Risk

About This 510(k) Submission

K250031 is an FDA 510(k) clearance for the Amplatzer Guidewire, a Wire, Guide, Catheter (Class II — Special Controls, product code DQX), submitted by Abbott Medical (St.Paul, US). The FDA issued a Cleared decision on October 3, 2025, 269 days after receiving the submission on January 7, 2025. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1330.

Submission Details

510(k) Number K250031 FDA.gov
FDA Decision Cleared SESE
Date Received January 07, 2025
Decision Date October 03, 2025
Days to Decision 269 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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