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U.S. Department of Health and Human Services

Product Classification
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Device gas control unit, cardiopulmonary bypass
Regulation Description Cardiopulmonary bypass gas control unit.
Regulation Medical Specialty Cardiovascular
Review Panel Cardiovascular
Product CodeDTX
Premarket Review Circulatory Support, Structural and Vascular Devices (DHT2B)
Circulatory Support, Structural and Vascular Devices (DHT2B)
Submission Type 510(k)
Regulation Number 870.4300
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
Third Party Review Not Third Party Eligible
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