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
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
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.

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
Combination Product No
PCCP Authorized No
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 Consultant

Terumo Medical Corporation
Liang Lu

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - DQX Wire, Guide, Catheter

All 739
Devices cleared under the same product code (DQX) and FDA review panel - the closest regulatory comparables to K163004.
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