Product Classification

• Device: temporary non-roller type left heart support blood pump
• Definition: A blood pump that provides temporary full or partial left heart support
• Physical State: Rotor or axial type pump manufactured of various materials. Single use, disposable.
• Technical Method: pumps part or all of the patient's blood circulation either during an adjunctive procedure where the patient requires hemodynamic stability, or a temporary use of the device to unload the heart to give it time to recover from an acute condition.
• Target Area: Heart
• Review Panel: Cardiovascular
• Product Code: OZD
• Premarket Review: Office of Cardiovascular Devices (OHT2); Circulatory Support, Structural and Vascular Devices (DHT2B)
• Submission Type: PMA
• 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