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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device ventricular bypass (assist) device
Regulation Description Ventricular bypass (assist) device.
Definition A ventricular bypass (assist) device is a device that assists the left or right ventricle in maintaining circulatory blood flow for <6 hours. The device is either totally or partially implanted in the body.
Product CodeOKR
Regulation Number 870.3545
Device Class 3

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