R2P Radifocus Glidewire Advantage
K-Number: K240818 · 2024-11-26
ApplicantTerumo Corporation
Decision Date2024-11-26
Product CodeDQX
Advisory CommitteeCV
DecisionSubstantially Equivalent
Device Summary
R2P Radifocus Glidewire Advantage is a medical device manufactured by Terumo Corporation. It received FDA 510(k) clearance on 2024-11-26 under approval 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. It is manufactured by Terumo Corporation. The 510(k) number is K240818.
When was R2P Radifocus Glidewire Advantage approved by the FDA?
R2P Radifocus Glidewire Advantage received FDA 510(k) clearance on 2024-11-26, under approval number K240818.
What company makes R2P Radifocus Glidewire Advantage?
R2P Radifocus Glidewire Advantage is manufactured by Terumo Corporation.
What is the FDA product code for R2P Radifocus Glidewire Advantage?
The FDA product code for R2P Radifocus Glidewire Advantage 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.