FDA 510(k)

Glidesheath Slender Tibial Pedal Kit

Número K: K193160 · 2019-12-03

Data da decisão2019-12-03

Código do produtoDYB

Comité consultivoCV

DecisãoSubstantially Equivalent

Resumo do dispositivo

Glidesheath Slender Tibial Pedal Kit is the device name listed in this FDA 510(k) record. The listed applicant is Terumo Medical Coporation. It received FDA 510(k) clearance on 2019-12-03 under 510(k) number K193160. The device is classified under product code DYB. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Glidesheath Slender Tibial Pedal Kit?

Glidesheath Slender Tibial Pedal Kit is a medical device that received FDA 510(k) clearance on 2019-12-03. The listed applicant is Terumo Medical Coporation. The 510(k) number is K193160.

When did Glidesheath Slender Tibial Pedal Kit receive FDA 510(k) clearance?

Glidesheath Slender Tibial Pedal Kit received FDA 510(k) clearance on 2019-12-03, under 510(k) number K193160.

Who is the listed applicant for Glidesheath Slender Tibial Pedal Kit?

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

What is the FDA product code for Glidesheath Slender Tibial Pedal Kit?

The FDA product code for Glidesheath Slender Tibial Pedal Kit is DYB.

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Fonte oficial

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