Cleared Traditional

Hi-Torque Command 14 ST Guide Wire and Hi-Torque Command 14 MT Guide Wire

K250552 · Abbott Medical · Cardiovascular
Jul 2025
Decision
150d
Days
Class 2
Risk

About This 510(k) Submission

K250552 is an FDA 510(k) clearance for the Hi-Torque Command 14 ST Guide Wire and Hi-Torque Command 14 MT Guide Wire, a Wire, Guide, Catheter (Class II — Special Controls, product code DQX), submitted by Abbott Medical (S,Mta Clara, US). The FDA issued a Cleared decision on July 25, 2025, 150 days after receiving the submission on February 25, 2025. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1330.

Submission Details

510(k) Number K250552 FDA.gov
FDA Decision Cleared SESE
Date Received February 25, 2025
Decision Date July 25, 2025
Days to Decision 150 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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