FDA 510(k)

R2P Radifocus Glidewire Advantage

K-Number: K240818 · 2024-11-26

Decision Date2024-11-26

Product CodeDQX

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

R2P Radifocus Glidewire Advantage is the device name listed in this FDA 510(k) record. The listed applicant is Terumo Corporation. It received FDA 510(k) clearance on 2024-11-26 under 510(k) number K240818. 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 R2P Radifocus Glidewire Advantage?

R2P Radifocus Glidewire Advantage is a medical device that received FDA 510(k) clearance on 2024-11-26. The listed applicant is Terumo Corporation. The 510(k) number is K240818.

When did R2P Radifocus Glidewire Advantage receive FDA 510(k) clearance?

R2P Radifocus Glidewire Advantage received FDA 510(k) clearance on 2024-11-26, under 510(k) number K240818.

Who is the listed applicant for R2P Radifocus Glidewire Advantage?

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 R2P Radifocus Glidewire Advantage?

The FDA product code for R2P Radifocus Glidewire Advantage is DQX.

Other records listing Terumo Corporation as applicant

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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.