FDA 510(k)

CentriMag Acute Circulatory Support System

N.º K: K191557 · 2019-07-10

SolicitanteThoratec Corporation (Now Part of Abbott)

Fecha de decisión2019-07-10

Código de productoDWA

Comité asesorCV

DecisiónSubstantially Equivalent

Resumen del dispositivo

CentriMag Acute Circulatory Support System is the device name listed in this FDA 510(k) record. The listed applicant is Thoratec Corporation (Now Part of Abbott). It received FDA 510(k) clearance on 2019-07-10 under 510(k) number K191557. The device is classified under product code DWA. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the CentriMag Acute Circulatory Support System?

CentriMag Acute Circulatory Support System is a medical device that received FDA 510(k) clearance on 2019-07-10. The listed applicant is Thoratec Corporation (Now Part of Abbott). The 510(k) number is K191557.

When did CentriMag Acute Circulatory Support System receive FDA 510(k) clearance?

CentriMag Acute Circulatory Support System received FDA 510(k) clearance on 2019-07-10, under 510(k) number K191557.

Who is the listed applicant for CentriMag Acute Circulatory Support System?

The FDA 510(k) record lists Thoratec Corporation (Now Part of Abbott) as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CentriMag Acute Circulatory Support System?

The FDA product code for CentriMag Acute Circulatory Support System is DWA.

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Dispositivos relacionados (Código: DWA)

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Fuente oficial

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