Cleared Traditional

K163004 - Radifocus Glidewire Advantage Track

K163004 is an FDA 510(k) clearance for Radifocus Glidewire Advantage Track, manufactured by Ashitaka Factory of Terumo Coporation. The device is a Class 2 Cardiovascular device with product code DQX cleared through the Traditional 510(k) pathway after a 94-day FDA review.

K163004 · Ashitaka Factory of Terumo Coporation · Cardiovascular device
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Jan 2017
Decision
94d
Days
Class 2
Risk

K163004 is an FDA 510(k) clearance for the Radifocus Glidewire Advantage Track. Classified as Wire, Guide, Catheter (product code DQX), Class II - Special Controls.

Submitted by Ashitaka Factory of Terumo Coporation (Fujinomiya Shizuoka, JP). The FDA issued a Cleared decision on January 30, 2017 after a review of 94 days - within the typical 510(k) review window.

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 Ashitaka Factory of Terumo Coporation devices

FDA 510(k) Submission Details - K163004

510(k) Number K163004 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 28, 2016
Decision Date January 30, 2017
Days to Decision 94 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
31d faster than avg
Panel avg: 125d · This submission: 94d
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 592
Devices cleared under the same product code (DQX) and FDA review panel - the closest regulatory comparables to K163004.
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K160785 · Argon Medical Devices, Inc. · Dec 2016