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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 Office of Device Evaluation (ODE)
Division of Cardiovascular Devices (DCD)
Circulatory Support Devices Branch (CSDB)
Submission Type 510(k)
Regulation Number 870.4230
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Guidance Document
  • Guidance for Extracorporeal Blood Circuit Defoamer 510(k) Submissions; Final Guidance for Industry and FDA
Third Party Review Not Third Party Eligible
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