||right ventricular bypass (assist) device|
||To provide circulatory support for patients in cardiogenic shock due to acute right ventricular failure.
||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.
||The blood pump is driven by a motor and controller, to propel blood from the right ventricle or atrium to the pulmonary circulation.
||right ventricle or atrium to pulmonary circulation
Office of Device Evaluation
Division of Cardiovascular Devices
Circulatory Support Devices Branch (CSDB)
HDE - Humanitarian Device Exemption
|Total Product Life Cycle (TPLC)
TPLC Product Code Report
|Third Party Review
||Not Third Party Eligible