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U.S. Department of Health and Human Services

Product Classification

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Device console, heart-lung machine, cardiopulmonary bypass
Regulation Description Cardiopulmonary bypass heart-lung machine console.
Regulation Medical Specialty Cardiovascular
Review Panel Cardiovascular
Product CodeDTQ
Premarket Review Office of Device Evaluation (ODE)
Division of Cardiovascular Devices (DCD)
Circulatory Support Devices Branch (CSDB)
Submission Type 510(k)
Regulation Number 870.4220
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Implanted Device? No
Life-Sustain/Support Device? Yes
Third Party Review Not Third Party Eligible