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U.S. Department of Health and Human Services

Product Classification
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Device oxygenator, long term support greater than 6 hours
Regulation Medical Specialty Cardiovascular
Review Panel Cardiovascular
Product CodeBYS
Premarket Review Cardiovascular Devices (OHT2)
Circulatory Support, Structural and Vascular Devices (DHT2B)
Submission Type 510(k)
Regulation Number 870.4100
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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