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FDA 510(k)

Peak Left Ventricular Vent Cannula, 20 Fr.; Peak Left Ventricular Vent Cannula, 18 Fr; Peak Left Ventricular Vent Cannula, 16 Fr

Número K: K170488 · 2017-08-10

RequerenteSurge Cardiovascular
Data da decisão2017-08-10
Código do produtoDWF
Comité consultivoCV
DecisãoSubstantially Equivalent

Resumo do dispositivo

Peak Left Ventricular Vent Cannula, 20 Fr.; Peak Left Ventricular Vent Cannula, 18 Fr; Peak Left Ventricular Vent Cannula, 16 Fr is the device name listed in this FDA 510(k) record. The listed applicant is Surge Cardiovascular. It received FDA 510(k) clearance on 2017-08-10 under 510(k) number K170488. The device is classified under product code DWF. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Peak Left Ventricular Vent Cannula, 20 Fr.; Peak Left Ventricular Vent Cannula, 18 Fr; Peak Left Ventricular Vent Cannula, 16 Fr?

Peak Left Ventricular Vent Cannula, 20 Fr.; Peak Left Ventricular Vent Cannula, 18 Fr; Peak Left Ventricular Vent Cannula, 16 Fr is a medical device that received FDA 510(k) clearance on 2017-08-10. The listed applicant is Surge Cardiovascular. The 510(k) number is K170488.

When did Peak Left Ventricular Vent Cannula, 20 Fr.; Peak Left Ventricular Vent Cannula, 18 Fr; Peak Left Ventricular Vent Cannula, 16 Fr receive FDA 510(k) clearance?

Peak Left Ventricular Vent Cannula, 20 Fr.; Peak Left Ventricular Vent Cannula, 18 Fr; Peak Left Ventricular Vent Cannula, 16 Fr received FDA 510(k) clearance on 2017-08-10, under 510(k) number K170488.

Who is the listed applicant for Peak Left Ventricular Vent Cannula, 20 Fr.; Peak Left Ventricular Vent Cannula, 18 Fr; Peak Left Ventricular Vent Cannula, 16 Fr?

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

What is the FDA product code for Peak Left Ventricular Vent Cannula, 20 Fr.; Peak Left Ventricular Vent Cannula, 18 Fr; Peak Left Ventricular Vent Cannula, 16 Fr?

The FDA product code for Peak Left Ventricular Vent Cannula, 20 Fr.; Peak Left Ventricular Vent Cannula, 18 Fr; Peak Left Ventricular Vent Cannula, 16 Fr is DWF.

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