FDA 510(k)

HQS Introducer (Model 2064-HQS)

N.º K: K153494 · 2016-08-25

SolicitanteAlseal

Fecha de decisión2016-08-25

Código de productoDYB

Comité asesorCV

DecisiónSubstantially Equivalent

Resumen del dispositivo

HQS Introducer (Model 2064-HQS) is the device name listed in this FDA 510(k) record. The listed applicant is Alseal. It received FDA 510(k) clearance on 2016-08-25 under 510(k) number K153494. 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 HQS Introducer (Model 2064-HQS)?

HQS Introducer (Model 2064-HQS) is a medical device that received FDA 510(k) clearance on 2016-08-25. The listed applicant is Alseal. The 510(k) number is K153494.

When did HQS Introducer (Model 2064-HQS) receive FDA 510(k) clearance?

HQS Introducer (Model 2064-HQS) received FDA 510(k) clearance on 2016-08-25, under 510(k) number K153494.

Who is the listed applicant for HQS Introducer (Model 2064-HQS)?

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

What is the FDA product code for HQS Introducer (Model 2064-HQS)?

The FDA product code for HQS Introducer (Model 2064-HQS) is DYB.

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Fuente oficial

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