Cleared Traditional

Worker Guidewire (K160785) - FDA 510(k) Clearance

Class II Cardiovascular device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K160785 · Argon Medical Devices, Inc. · Cardiovascular device
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Optimized for regulatory review, auditing and printing
Dec 2016
Decision
261d
Days
Class 2
Risk

K160785 is an FDA 510(k) clearance for the Worker Guidewire. Classified as Wire, Guide, Catheter (product code DQX), Class II - Special Controls.

Submitted by Argon Medical Devices, Inc. (Athens, US). The FDA issued a Cleared decision on December 8, 2016 after a review of 261 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1330 - the FDA cardiovascular device oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

View all Argon Medical Devices, Inc. devices

Submission Details

510(k) Number K160785 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
136d slower than avg
Panel avg: 125d · This submission: 261d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DQX Wire, Guide, Catheter
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1330
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Cardiovascular devices follow this clearance model.

Regulatory Peers - DQX Wire, Guide, Catheter

All 252
Devices cleared under the same product code (DQX) and FDA review panel - the closest regulatory comparables to K160785.
Inqwire Diagnostic Guide Wire
K163575 · Merit Medical Systems, Inc. · Mar 2017
ASAHI PTCA Guide Wire ASAHI SUOH 03
K162842 · Asahi Intecc Co., Ltd. · Jan 2017
Spectre guidewire
K163444 · Vascular Solutions, Inc. · Jan 2017
Hornet Guidewire, Hornet 10 Guidewire, Hornet 14 Guidewire
K152231 · Boston Scientific Corporation · Feb 2016
Fighter Guidewire, Marvel Guidewire, Samurai Guidewire, Samurai RC Guidewire, Stretch Extension Wire
K151840 · Boston Scientific Corporation · Dec 2015
Heavy Double Flexible Tipped Wire Guide
K150802 · Cook Incorporated · May 2015