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FDA 510(k)

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 the device name listed in this FDA 510(k) record. The listed applicant is Terumo Corporation. It received FDA 510(k) clearance on 2024-08-21 under 510(k) 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. The listed applicant is Terumo Corporation. The 510(k) number is K240859.

When did Glidewire GT-R receive FDA 510(k) clearance?

Glidewire GT-R received FDA 510(k) clearance on 2024-08-21, under 510(k) number K240859.

Who is the listed applicant for Glidewire GT-R?

The FDA 510(k) record lists Terumo Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Glidewire GT-R?

The FDA product code for Glidewire GT-R is DQX.

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Related Devices (Code: 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.

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