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U.S. Department of Health and Human Services

Product Classification

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Device valve, pressure relief, cardiopulmonary bypass
Regulation Description Cardiopulmonary bypass blood reservoir.
Regulation Medical Specialty Cardiovascular
Review Panel Cardiovascular
Product CodeMNJ
Premarket Review Office of Device Evaluation (ODE)
Division of Cardiovascular Devices (DCD)
Circulatory Support Devices Branch (CSDB)
Submission Type 510(k)
Regulation Number 870.4400
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible