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U.S. Department of Health and Human Services

Product Classification

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Device filter, blood, cardiopulmonary bypass, arterial line
Regulation Description Cardiopulmonary bypass arterial line blood filter.
Regulation Medical Specialty Cardiovascular
Review Panel Cardiovascular
Product CodeDTM
Premarket Review Office of Device Evaluation (ODE)
Division of Cardiovascular Devices (DCD)
Circulatory Support Devices Branch (CSDB)
Submission Type 510(k)
Regulation Number 870.4260
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Guidance Document
  • Guidance for Cardiopulmonary Bypass Arterial Line Blood Filter 510(k) Submissions; Final Guidance for Industry and FDA
Implanted Device? No
Life-Sustain/Support Device? Yes
Third Party Review Not Third Party Eligible