Product Classification

• 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 Code: OJE
• Premarket Review: Office of Cardiovascular Devices (OHT2); 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

Recognized Consensus Standards

• 3-165 ASTM F1841-19
  Standard Practice for Assessment of Hemolysis in Continuous Flow Blood Pumps
• 3-199 ASTM F1841-25
  Standard Practice for Assessment of Hemolysis in Blood Pumps

Third Party Review

Not Third Party Eligible