Product Classification

• Device: extracorporeal system for long-term respiratory / cardiopulmonary failure
• Regulation Description: Extracorporeal circuit and accessories for long-term respiratory/cardiopulmonary failure.
• Definition: Extracorporeal circuit and accessories for long-term respiratory/cardiopulmonary failure.
• Physical State: May include an oxygenator, pump, and other components needed for perfusion.
• Technical Method: Device removes blood from blood vessels and pumps blood through an oxygenator for gas exchange and returns the blood to the blood vessels.
• Target Area: Blood vessels, heart, lungs.
• Regulation Medical Specialty: Cardiovascular
• Review Panel: Cardiovascular
• Product Code: QJZ
• Premarket Review: Circulatory Support, Structural and Vascular Devices (DHT2B); Circulatory Support, Structural and Vascular Devices (DHT2B)
• Submission Type: 510(k)
• Regulation Number: 870.4100
• Device Class: 2
• 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
• 3-183 ISO 11658 First edition 2012-05-15
  Cardiovascular implants and extracorporeal systems - Blood/tissue contact surface modifications for extracorporeal perfusion systems
• 3-199 ASTM F1841-25
  Standard Practice for Assessment of Hemolysis in Blood Pumps

Third Party Review

Not Third Party Eligible