FDA 510(k)

Sheath Introducer

N.º K: K150932 · 2016-07-22

Fecha de decisión2016-07-22

Código de productoDRE

Comité asesorCV

DecisiónSubstantially Equivalent

Resumen del dispositivo

Sheath Introducer is the device name listed in this FDA 510(k) record. The listed applicant is Bioteque Corp.. It received FDA 510(k) clearance on 2016-07-22 under 510(k) number K150932. The device is classified under product code DRE. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the Sheath Introducer?

Sheath Introducer is a medical device that received FDA 510(k) clearance on 2016-07-22. The listed applicant is Bioteque Corp.. The 510(k) number is K150932.

When did Sheath Introducer receive FDA 510(k) clearance?

Sheath Introducer received FDA 510(k) clearance on 2016-07-22, under 510(k) number K150932.

Who is the listed applicant for Sheath Introducer?

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

What is the FDA product code for Sheath Introducer?

The FDA product code for Sheath Introducer is DRE.

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Fuente oficial

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