Cleared Traditional

K160785 - Worker Guidewire

K160785 is an FDA 510(k) clearance for Worker Guidewire, manufactured by Argon Medical Devices, Inc.. The device is a Class 2 Cardiovascular device with product code DQX cleared through the Traditional 510(k) pathway after a 261-day FDA review.

K160785 · Argon Medical Devices, Inc. · Cardiovascular device
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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

FDA 510(k) Submission Details - K160785

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.

DQX Device Classification - Class 2, Special Controls

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 541
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
Endura guidewire
K161702 · Vascular Solutions, Inc. · Dec 2016
ASAHI® Peripheral Vascular Guide Wire ASAHI Meister®16
K161584 · Asahi Intecc Co., Ltd. · Oct 2016
Verrata PLUS Pressure Guide Wire, 185 cm Straight Tip, Verrata PLUS Pressure Guide Wire, 185 cm J-Tip, Verrata PLUS Pressure Guide Wire, 300 cm Straight Tip, Verrata PLUS Pressure Guide Wire, 300 cm J-Tip
K161887 · Volcano Corporation · Sep 2016