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U.S. Department of Health and Human Services

Product Classification

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Device cpb check valve, retrograde flow, in-line
Regulation Description Cardiopulmonary bypass blood reservoir.
Regulation Medical Specialty Cardiovascular
Review Panel Cardiovascular
Product CodeMJJ
Premarket Review Office of Cardiovascular Devices (OHT2)
Circulatory Support, Structural and Vascular Devices (DHT2B)
Submission Type 510(k)
Regulation Number 870.4400
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
Third Party Review
Accredited Persons
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