Cleared Special

HI-TORQUE PROCEED Guide Wire Family

K201834 · Abbott Vascular · Cardiovascular
Jul 2020
Decision
28d
Days
Class 2
Risk

About This 510(k) Submission

K201834 is an FDA 510(k) clearance for the HI-TORQUE PROCEED Guide Wire Family, a Wire, Guide, Catheter (Class II — Special Controls, product code DQX), submitted by Abbott Vascular (Santa Clara, US). The FDA issued a Cleared decision on July 30, 2020, 28 days after receiving the submission on July 2, 2020. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1330.

Submission Details

510(k) Number K201834 FDA.gov
FDA Decision Cleared SESE
Date Received July 02, 2020
Decision Date July 30, 2020
Days to Decision 28 days
Submission Type Special
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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