Cleared Traditional

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

K240997 · Abbott Medical · Cardiovascular
Nov 2024
Decision
209d
Days
Class 2
Risk

About This 510(k) Submission

K240997 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 November 6, 2024, 209 days after receiving the submission on April 11, 2024. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1330.

Submission Details

510(k) Number K240997 FDA.gov
FDA Decision Cleared SESE
Date Received April 11, 2024
Decision Date November 06, 2024
Days to Decision 209 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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