Cleared Traditional

Glidewire GT

K170417 · Terumo Corporation · Cardiovascular
Sep 2017
Decision
217d
Days
Class 2
Risk

About This 510(k) Submission

K170417 is an FDA 510(k) clearance for the Glidewire GT, a Wire, Guide, Catheter (Class II — Special Controls, product code DQX), submitted by Terumo Corporation (Shibuya-Ku, JP). The FDA issued a Cleared decision on September 15, 2017, 217 days after receiving the submission on February 10, 2017. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1330.

Submission Details

510(k) Number K170417 FDA.gov
FDA Decision Cleared 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

Device Classification

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

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