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U.S. Department of Health and Human Services

Product Classification

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Device defoamer, cardiopulmonary bypass
Regulation Description Cardiopulmonary bypass defoamer.
Regulation Medical Specialty Cardiovascular
Review Panel Cardiovascular
Product CodeDTP
Premarket Review Circulatory Support, Structural and Vascular Devices (DHT2B)
Circulatory Support, Structural and Vascular Devices (DHT2B)
Submission Type 510(k)
Regulation Number 870.4230
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
Guidance Documents
Third Party Review Not Third Party Eligible
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