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U.S. Department of Health and Human Services

Product Classification
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Device right ventricular bypass (assist) device
Definition To provide circulatory support for patients in cardiogenic shock due to acute right ventricular failure.
Physical State The system is comprised of a blood pump, motor, drive console, flow sensor, and inlet and outlet cannulae. The blood pump is single-use only but the other components can be reused.
Technical Method The blood pump is driven by a motor and controller, to propel blood from the right ventricle or atrium to the pulmonary circulation.
Target Area right ventricle or atrium to pulmonary circulation
Review Panel Cardiovascular
Product CodeOJE
Premarket Review Circulatory Support, Structural and Vascular Devices (DHT2B)
Circulatory Support, Structural and Vascular Devices (DHT2B)
Submission Type HDE - Humanitarian Device Exemption
Device Class HDE
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Reporting		 Ineligible
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible
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