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U.S. Department of Health and Human Services

Product Classification

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Device oxygenator, cardiopulmonary bypass
Regulation Description Cardiopulmonary bypass oxygenator.
Regulation Medical Specialty Cardiovascular
Review Panel Cardiovascular
Product CodeDTZ
Premarket Review Office of Cardiovascular Devices (OHT2)
Circulatory Support, Structural and Vascular Devices (DHT2B)
Submission Type 510(k)
Regulation Number 870.4350
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 Standards
Guidance Documents
Third Party Review Not Third Party Eligible
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