FDA 510(k)

Worker Guidewire

N.º K: K160785 · 2016-12-08

Fecha de decisión2016-12-08

Código de productoDQX

Comité asesorCV

DecisiónSubstantially Equivalent

Resumen del dispositivo

Worker Guidewire is the device name listed in this FDA 510(k) record. The listed applicant is Argon Medical Devices, Inc.. It received FDA 510(k) clearance on 2016-12-08 under 510(k) number K160785. The device is classified under product code DQX. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the Worker Guidewire?

Worker Guidewire is a medical device that received FDA 510(k) clearance on 2016-12-08. The listed applicant is Argon Medical Devices, Inc.. The 510(k) number is K160785.

When did Worker Guidewire receive FDA 510(k) clearance?

Worker Guidewire received FDA 510(k) clearance on 2016-12-08, under 510(k) number K160785.

Who is the listed applicant for Worker Guidewire?

The FDA 510(k) record lists Argon Medical Devices, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Worker Guidewire?

The FDA product code for Worker Guidewire is DQX.

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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.