Product Classification

• Device: oxygenator, cardiopulmonary bypass
• Regulation Description: Cardiopulmonary bypass oxygenator.
• Regulation Medical Specialty: Cardiovascular
• Review Panel: Cardiovascular
• Product Code: DTZ
• Submission Type: 510(k)
• Regulation Number: 870.4350
• Device Class: 2
• Total Product Life Cycle (TPLC): TPLC Product Code Report
• GMP Exempt?: No

Recognized Consensus Standards

• AAMI/ANSI/ISO 7199:2009 Cardiovascular implants and artificial organs - Blood gas exchangers (oxygenators)
• ISO 7199 Second edition 2009-04-15 Cardiovascular implants and artificial organs - Blood-gas exchangers (oxygenators)

Third Party Review

Not Third Party Eligible