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U.S. Department of Health and Human Services

Product Classification

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Device pediatric ventricular assist device
Regulation Description Ventricular bypass (assist) device.
Definition A ventricular assist device (vad) assists the left or right ventricle in maintaining circulatory blood flow.The device is either totally or partially implanted in the body.
Physical State Ventricular assist devices may come in many shapes (depending on pulsatile or continuous flow, and mechanism of function) and sizes (depending on size of the patient). They utilize different functions to achieve replacement of the primary function of the ventricle. Generally, the pump itself has both plastic and metal components. Cannulae/catheters attaching to the ventricles and/or arteries are made of plastic. In addition to the pump, the system also generally has a driver where the pump function (speed, pressure, etc.) can be monitored and controlled.
Technical Method Uses mechanical means to replace function of the left and/or right ventricles. For left ventricular support, blood is pumped from the left ventricle to the aortic arch. For right ventricular support, blood is pumped from the right ventricle to the pulmonary arteries.
Target Area Heart; Cardiovascular System
Regulation Medical Specialty Cardiovascular
Review Panel Cardiovascular
Product CodePCK
Premarket Review Office of Device Evaluation (ODE)
Division of Cardiovascular Devices (DCD)
Circulatory Support Devices Branch (CSDB)
Submission Type HDE - Humanitarian Device Exemption
Regulation Number 870.3545
Device Class HDE - Humanitarian Device Exemption
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Third Party Review Not Third Party Eligible
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