Cleared Traditional

Worker Guidewire

K160785 · Argon Medical Devices, Inc. · Cardiovascular
Dec 2016
Decision
261d
Days
Class 2
Risk

About This 510(k) Submission

K160785 is an FDA 510(k) clearance for the Worker Guidewire, a Wire, Guide, Catheter (Class II — Special Controls, product code DQX), submitted by Argon Medical Devices, Inc. (Athens, US). The FDA issued a Cleared decision on December 8, 2016, 261 days after receiving the submission on March 22, 2016. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1330.

Submission Details

510(k) Number K160785 FDA.gov
FDA Decision Cleared SESE
Date Received March 22, 2016
Decision Date December 08, 2016
Days to Decision 261 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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