Product Classification

• Device: dual lumen ecmo cannula
• Regulation Description: Extracorporeal circuit and accessories for long-term respiratory/cardiopulmonary failure.
• Definition: Long term support greater than 6 hours for acute respiratory or acute cardiopulmonary failure, where other available treatment options have failed, and continued clinical deterioration is expected or the risk of death is imminent.
• Physical State: The device consists of a catheter with dual lumens. Holes in the outer and inner lumens allow for ingress and egress of blood.
• Technical Method: The device is inserted into the vasculature and connected to other devices in the ECMO circuit to allow for drainage and reinfusion of blood during ECMO procedures.
• Target Area: The device is inserted into the vasculature and connected to the extracorporeal circuit to allow for circulation of blood.
• Regulation Medical Specialty: Cardiovascular
• Review Panel: Cardiovascular
• Product Code: PZS
• 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: Ineligible
• Implanted Device?: No
• Life-Sustain/Support Device?: No

Recognized Consensus Standards

• 3-176 ISO 18193 First edition 2021-08
  Cardiovascular implants and artificial organs - Cannulae for extracorporeal circulation
• 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