Cleared Traditional

Glidewire GT (K170417) - FDA 510(k) Clearance

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

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

Submission Details

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.

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 K170417.
Roadrunner Extra Support Wire Guide
K171948 · Cook Incorporated · Jan 2018
Raider Guidewire
K173532 · Vascular Solutions, Inc. · Dec 2017
WATCHDOG Hemostasis Valve Kit
K172453 · Boston Scientific Corporation · Nov 2017
Approach CTO Microwire Guide
K171897 · Cook Incorporated · Aug 2017
True Form Reshapable Guide Wire
K170532 · Merit Medical Systems, Inc. · Jul 2017
Merit Hydrophilic Guide Wire
K170933 · Merit Medical Systems, Inc. · Jun 2017