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U.S. Department of Health and Human Services

Product Classification

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Device 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.
Physical State 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.
Technical Method 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.
Target Area 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.
Regulation Medical Specialty Cardiovascular
Review Panel Cardiovascular
Product CodeOKR
Premarket Review Cardiovascular Devices (OHT2)
Circulatory Support, Structural and Vascular Devices (DHT2B)
Submission Type PMA
Regulation Number 870.3545
Device Class 3
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Reporting
Eligible
Implanted Device? No
Life-Sustain/Support Device? No
Recognized Consensus Standards
Third Party Review Not Third Party Eligible
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