FDA 510(k)

Cook 810 Set, Desilets-Hoffman Introducer Set

N.º K: K180028 · 2018-05-02

Fecha de decisión2018-05-02

Código de productoEZN

Comité asesorGU

DecisiónSubstantially Equivalent

Resumen del dispositivo

Cook 810 Set, Desilets-Hoffman Introducer Set is the device name listed in this FDA 510(k) record. The listed applicant is Cook Incorporated. It received FDA 510(k) clearance on 2018-05-02 under 510(k) number K180028. The device is classified under product code EZN. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the Cook 810 Set, Desilets-Hoffman Introducer Set?

Cook 810 Set, Desilets-Hoffman Introducer Set is a medical device that received FDA 510(k) clearance on 2018-05-02. The listed applicant is Cook Incorporated. The 510(k) number is K180028.

When did Cook 810 Set, Desilets-Hoffman Introducer Set receive FDA 510(k) clearance?

Cook 810 Set, Desilets-Hoffman Introducer Set received FDA 510(k) clearance on 2018-05-02, under 510(k) number K180028.

Who is the listed applicant for Cook 810 Set, Desilets-Hoffman Introducer Set?

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

What is the FDA product code for Cook 810 Set, Desilets-Hoffman Introducer Set?

The FDA product code for Cook 810 Set, Desilets-Hoffman Introducer Set is EZN.

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Fuente oficial

Ver en la base de datos de la FDA →

Datos procedentes de la API abierta de la FDA. Para obtener la información más actualizada y autoritativa, consulte siempre el registro oficial.