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U.S. Department of Health and Human Services

Product Classification

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Device microfilter, blood transfusion
Regulation Description Intravascular administration set.
Regulation Medical Specialty General Hospital
Review Panel General Hospital
Product CodeCAK
Premarket Review Center for Biologics Evaluation & Research (CBER)
Submission Type 510(k)
Regulation Number 880.5440
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Recognized Consensus Standards
Guidance Document
  • Guidance for Industry and FDA Review Staff - Intravascular Administration Sets Premarket Notification Submissions [510(k)]
Third Party Review Not Third Party Eligible
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