FDA 510(k)

Swan Ganz Catheters

N.º K: K160084 · 2016-05-03

Fecha de decisión2016-05-03

Código de productoDYG

Comité asesorCV

DecisiónSubstantially Equivalent

Resumen del dispositivo

Swan Ganz Catheters is the device name listed in this FDA 510(k) record. The listed applicant is Edwards Lifesciences, LLC. It received FDA 510(k) clearance on 2016-05-03 under 510(k) number K160084. The device is classified under product code DYG. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the Swan Ganz Catheters?

Swan Ganz Catheters is a medical device that received FDA 510(k) clearance on 2016-05-03. The listed applicant is Edwards Lifesciences, LLC. The 510(k) number is K160084.

When did Swan Ganz Catheters receive FDA 510(k) clearance?

Swan Ganz Catheters received FDA 510(k) clearance on 2016-05-03, under 510(k) number K160084.

Who is the listed applicant for Swan Ganz Catheters?

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

What is the FDA product code for Swan Ganz Catheters?

The FDA product code for Swan Ganz Catheters is DYG.

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Dispositivos relacionados (Código: DYG)

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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.