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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 blood pump.
Regulation Medical Specialty Cardiovascular
Review Panel Cardiovascular
Product CodeKFM
Premarket Review Office of Cardiovascular Devices (OHT2)
Circulatory Support, Structural and Vascular Devices (DHT2B)
Submission Type 510(k)
Regulation Number 870.4360
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 Standards
Third Party Review Not Third Party Eligible
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