Product Classification

• Device: oxygenator, long term support greater than 6 hours
• Regulation Description: Extracorporeal circuit and accessories for long-term respiratory/cardiopulmonary failure.
• Regulation Medical Specialty: Cardiovascular
• Review Panel: Cardiovascular
• Product Code: BYS
• Premarket Review: Office of Cardiovascular Devices (OHT2); 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: Eligible
• Implanted Device?: No
• Life-Sustain/Support Device?: Yes

Recognized Consensus Standard

• 3-183 ISO 11658 First edition 2012-05-15
  Cardiovascular implants and extracorporeal systems - Blood/tissue contact surface modifications for extracorporeal perfusion systems

Third Party Review

Not Third Party Eligible