FDA 510(k)

Radifocus Glidewire Advantage Track

Número K: K163004 · 2017-01-30

RequerenteAshitaka Factory of Terumo Coporation

Data da decisão2017-01-30

Código do produtoDQX

Comité consultivoCV

DecisãoSubstantially Equivalent

Resumo do dispositivo

Radifocus Glidewire Advantage Track is the device name listed in this FDA 510(k) record. The listed applicant is Ashitaka Factory of Terumo Coporation. It received FDA 510(k) clearance on 2017-01-30 under 510(k) number K163004. The device is classified under product code DQX. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

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. The listed applicant is Ashitaka Factory of Terumo Coporation. The 510(k) number is K163004.

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

Radifocus Glidewire Advantage Track received FDA 510(k) clearance on 2017-01-30, under 510(k) number K163004.

Who is the listed applicant for Radifocus Glidewire Advantage Track?

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

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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