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U.S. Department of Health and Human Services

Product Classification

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Device catheter,intravascular,therapeutic,short-term less than 30 days
Regulation Description Intravascular catheter.
Regulation Medical Specialty General Hospital
Review Panel General Hospital
Product CodeFOZ
Premarket Review Office of Device Evaluation (ODE)
Division of Anesthesiology, General Hospital, Infection Control, and Dental Devices (DAGRID)
General Hospital Devices Branch (GHDB)
Submission Type 510(k)
Regulation Number 880.5200
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Recognized Consensus Standards
Guidance Document
  • Guidance on Premarket Notification [510(K)] Submissions for Short-Term and Long-Term Intravascular Catheters [http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM080766.pdf] 
Third Party Review
Accredited Persons

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