Cleared Traditional

K170417 - Glidewire GT

K170417 is an FDA 510(k) clearance for Glidewire GT, manufactured by Terumo Corporation. The device is a Class 2 Cardiovascular device with product code DQX cleared through the Traditional 510(k) pathway after a 217-day FDA review.

K170417 · Terumo Corporation · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2017
Decision
217d
Days
Class 2
Risk

K170417 is an FDA 510(k) clearance for the Glidewire GT. Classified as Wire, Guide, Catheter (product code DQX), Class II - Special Controls.

Submitted by Terumo Corporation (Shibuya-Ku, JP). The FDA issued a Cleared decision on September 15, 2017 after a review of 217 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 Terumo Corporation devices

FDA 510(k) Submission Details - K170417

510(k) Number K170417 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 10, 2017
Decision Date September 15, 2017
Days to Decision 217 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
92d slower than avg
Panel avg: 125d · This submission: 217d
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 K170417.
Roadrunner Extra Support Wire Guide
K171948 · Cook Incorporated · Jan 2018
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K173532 · Vascular Solutions, Inc. · Dec 2017
WATCHDOG Hemostasis Valve Kit
K172453 · Boston Scientific Corporation · Nov 2017
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K172073 · Abbott Vascular · Aug 2017
Approach CTO Microwire Guide
K171897 · Cook Incorporated · Aug 2017
True Form Reshapable Guide Wire
K170532 · Merit Medical Systems, Inc. · Jul 2017