Product Classification

• Device: temporary non-roller type right heart support blood pump
• Regulation Description: Nonroller-type blood pump.
• Definition: Providing temporary partial or full right heart circulatory support.
• Physical State: Rotor or axial type pump manufactured of various materials. Single use, disposable.
• Technical Method: Assists with partial or full right heart blood circulation either during an adjunctive procedure where the patient requires hemodynamic stability, or a temporary use of the device to unload the right heart to give it time to recover from an acute condition.
• Target Area: Heart.
• Regulation Medical Specialty: Cardiovascular
• Review Panel: Cardiovascular
• Product Code: PYX
• Premarket Review: Office of Cardiovascular Devices (OHT2); Circulatory Support, Structural and Vascular Devices (DHT2B)
• Submission Type: PMA
• Regulation Number: 870.4360
• Device Class: 3
• Total Product Life Cycle (TPLC): TPLC Product Code Report
• GMP Exempt?: No
• Summary Malfunction Reporting: Ineligible
• Implanted Device?: No
• Life-Sustain/Support Device?: Yes

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