• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Product Classification

  • Print
  • Share
  • E-mail
-
New Search Back To Search Results
Device subcutaneous implanted apheresis port
Regulation Description Subcutaneous, implanted, intravascular infusion port and catheter.
Definition A subcutaneous implanted apheresis port is a prescription device intended for patient therapies requiring repeated access to the vascular system and long-term therapeutic apheresis.
Physical State A subcutaneous implanted apheresis port includes the port body, intravascular catheter, and over-the-needle I.V. catheter for port access.
Technical Method An apheresis port is for patient therapies requiring repeated access to the vascular system. The port system can be used for the infusion of medications, I.V. fluids, parenteral nutrition solutions, blood and blood products, withdrawal of blood and long-term therapeutic apheresis.
Target Area In accordance with FDA approved labeling, a subcutaneous implanted apheresis port is a prescription device intended for patient therapies requiring repeated access to the vascular system and long-term therapeutic apheresis.
Regulation Medical Specialty General Hospital
Review Panel General Hospital
Product CodePTD
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 880.5965
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Implanted Device? Yes
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible
-
-