Glidewire GT-R
K-Number: K240859 · 2024-08-21
ApplicantTerumo Corporation
Decision Date2024-08-21
Product CodeDQX
Advisory CommitteeCV
DecisionSubstantially Equivalent
Device Summary
Glidewire GT-R is a medical device manufactured by Terumo Corporation. It received FDA 510(k) clearance on 2024-08-21 under approval number K240859. The device is classified under product code DQX. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Glidewire GT-R?
Glidewire GT-R is a medical device that received FDA 510(k) clearance on 2024-08-21. It is manufactured by Terumo Corporation. The 510(k) number is K240859.
When was Glidewire GT-R approved by the FDA?
Glidewire GT-R received FDA 510(k) clearance on 2024-08-21, under approval number K240859.
What company makes Glidewire GT-R?
Glidewire GT-R is manufactured by Terumo Corporation.
What is the FDA product code for Glidewire GT-R?
The FDA product code for Glidewire GT-R is DQX.
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Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.