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U.S. Department of Health and Human Services

Product Classification

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Device pump, blood, cardiopulmonary bypass, non-roller type
Regulation Description Nonroller-type cardiopulmonary bypass blood pump.
Regulation Medical Specialty Cardiovascular
Review Panel Cardiovascular
Product CodeKFM
Premarket Review Office of Device Evaluation (ODE)
Division of Cardiovascular Devices (DCD)
Circulatory Support Devices Branch (CSDB)
Submission Type 510(k)
Regulation Number 870.4360
Device Class 3
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Recognized Consensus Standards
Third Party Review Not Third Party Eligible
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