FDA 510(k)

Glidesheath Slender Tibial Pedal Kit

N.º K: K181237 · 2018-08-03

Fecha de decisión2018-08-03

Código de productoDYB

Comité asesorCV

DecisiónSubstantially Equivalent

Resumen del dispositivo

Glidesheath Slender Tibial Pedal Kit is the device name listed in this FDA 510(k) record. The listed applicant is Terumo Medical Corporation. It received FDA 510(k) clearance on 2018-08-03 under 510(k) number K181237. The device is classified under product code DYB. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the Glidesheath Slender Tibial Pedal Kit?

Glidesheath Slender Tibial Pedal Kit is a medical device that received FDA 510(k) clearance on 2018-08-03. The listed applicant is Terumo Medical Corporation. The 510(k) number is K181237.

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

Glidesheath Slender Tibial Pedal Kit received FDA 510(k) clearance on 2018-08-03, under 510(k) number K181237.

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

The FDA 510(k) record lists Terumo Medical Corporation 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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Fuente oficial

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