FDA 510(k)

Swan-Ganz Catheters

N.º K: K193466 · 2020-02-16

Fecha de decisión2020-02-16

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 2020-02-16 under 510(k) number K193466. 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 2020-02-16. The listed applicant is Edwards Lifesciences, LLC. The 510(k) number is K193466.

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

Swan-Ganz Catheters received FDA 510(k) clearance on 2020-02-16, under 510(k) number K193466.

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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Otros registros que enlistan a Edwards Lifesciences, LLC como solicitante

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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.