Radifocus Glidewire Advantage Track
K-Number: K163004 · 2017-01-30
Decision Date2017-01-30
Product CodeDQX
Advisory CommitteeCV
DecisionSubstantially Equivalent
Device Summary
Radifocus Glidewire Advantage Track is a medical device manufactured by Ashitaka Factory of Terumo Coporation. It received FDA 510(k) clearance on 2017-01-30 under approval number K163004. 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 Radifocus Glidewire Advantage Track?
Radifocus Glidewire Advantage Track is a medical device that received FDA 510(k) clearance on 2017-01-30. It is manufactured by Ashitaka Factory of Terumo Coporation. The 510(k) number is K163004.
When was Radifocus Glidewire Advantage Track approved by the FDA?
Radifocus Glidewire Advantage Track received FDA 510(k) clearance on 2017-01-30, under approval number K163004.
What company makes Radifocus Glidewire Advantage Track?
Radifocus Glidewire Advantage Track is manufactured by Ashitaka Factory of Terumo Coporation.
What is the FDA product code for Radifocus Glidewire Advantage Track?
The FDA product code for Radifocus Glidewire Advantage Track 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.