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U.S. Department of Health and Human Services

Product Classification
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Device apparatus, autotransfusion
Regulation Description Autotransfusion apparatus.
Regulation Medical Specialty Anesthesiology
Review Panel Cardiovascular
Product CodeCAC
Premarket Review Office of Cardiovascular Devices (OHT2)
Circulatory Support, Structural and Vascular Devices (DHT2B)
Submission Type 510(k)
Regulation Number 868.5830
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? Yes
Recognized Consensus Standard
Third Party Review Not Third Party Eligible
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