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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 Description Extracorporeal circuit and accessories for long-term respiratory/cardiopulmonary failure.
Regulation Medical Specialty Cardiovascular
Review Panel Cardiovascular
Product CodeBYS
Premarket Review Circulatory Support, Structural and Vascular Devices (DHT2B)
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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