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U.S. Department of Health and Human Services

Product Classification

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Device filter, blood, cardiotomy suction line, cardiopulmonary bypass
Regulation Description Cardiopulmonary bypass cardiotomy suction line blood filter.
Regulation Medical Specialty Cardiovascular
Review Panel Cardiovascular
Product CodeJOD
Premarket Review Office of Cardiovascular Devices (OHT2)
Circulatory Support, Structural and Vascular Devices (DHT2B)
Submission Type 510(k)
Regulation Number 870.4270
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 Standard
Third Party Review
Accredited Persons
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