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U.S. Department of Health and Human Services

Product Classification
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Device heat-exchanger, cardiopulmonary bypass
Regulation Description Cardiopulmonary bypass heat exchanger.
Regulation Medical Specialty Cardiovascular
Review Panel Cardiovascular
Product CodeDTR
Premarket Review Circulatory Support, Structural and Vascular Devices (DHT2B)
Circulatory Support, Structural and Vascular Devices (DHT2B)
Submission Type 510(k)
Regulation Number 870.4240
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
Third Party Review Not Third Party Eligible
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