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U.S. Department of Health and Human Services

Product Classification

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Device reservoir, blood, cardiopulmonary bypass
Regulation Description Cardiopulmonary bypass blood reservoir.
Regulation Medical Specialty Cardiovascular
Review Panel Cardiovascular
Product CodeDTN
Premarket Review Office of Cardiovascular Devices (OHT2)
Circulatory Support, Structural and Vascular Devices (DHT2B)
Submission Type 510(k)
Regulation Number 870.4400
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? No
Recognized Consensus Standard
Guidance Document
Third Party Review
Accredited Persons
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