Cleared Traditional

Glidewire GT-R

K240859 · Terumo Corporation · Cardiovascular
Aug 2024
Decision
146d
Days
Class 2
Risk

About This 510(k) Submission

K240859 is an FDA 510(k) clearance for the Glidewire GT-R, a Wire, Guide, Catheter (Class II — Special Controls, product code DQX), submitted by Terumo Corporation (Tokyo, JP). The FDA issued a Cleared decision on August 21, 2024, 146 days after receiving the submission on March 28, 2024. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1330.

Submission Details

510(k) Number K240859 FDA.gov
FDA Decision Cleared SESE
Date Received March 28, 2024
Decision Date August 21, 2024
Days to Decision 146 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF

Device Classification

Product Code DQX — Wire, Guide, Catheter
Device Class Class II — Special Controls
CFR Regulation 21 CFR 870.1330

Similar Devices — DQX Wire, Guide, Catheter

All 760
EmeryGlide? (EG18008901)
K253262 · Nano4imaging GmbH · Mar 2026
Splashwire Hydrophilic Guide Wire (MSWSTD35150J3)
K253847 · Merit Medical Ireland, Ltd. · Jan 2026
InQwire Super Stiff Guide Wire (IQSS32180J3); InQwire Super Stiff Guide Wire (IQSS35F260S); InQwire Super Stiff Guide Wire (IQSS35F150S); InQwire Super Stiff Guide Wire (IQSS35F100S); InQwire Super Stiff Guide Wire (IQSS35F80S); InQwire Super Stiff Guide Wire (IQSS35F180S)
K251385 · Merit Medical Ireland, Ltd. · Jan 2026
Solo Pace Fusion System (SOLOFUSE1)
K252674 · Solo Pace, Inc. · Jan 2026
Lunderquist Extra Stiff Wire Guide
K251596 · William Cook Europe Aps · Nov 2025
SureAx-Guide?
K250203 · Sureax Medical, LLC · Oct 2025