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U.S. FDA Medical Device High Permeability Hemodialysis System Requirements: High Permeability Hemodialysis System

FDA Medical Device Definition: A high permeability hemodialysis system is a device intended for use as an artificial kidney system for the treatment of patients with renal failure, fluid overload, or toxemic conditions by performing such therapies as hemodialysis, hemofiltration, hemoconcentration, and hemodiafiltration. Using a hemodialyzer with a semipermeable membrane that is more permeable to water than the semipermeable membrane of the conventional hemodialysis system (876.5820), the high permeability hemodialysis system removes toxins or excess fluid from the patient's blood using the principles of convection (via a high ultrafiltration rate) and/or diffusion (via a concentration gradient in dialysate). During treatment, blood is circulated from the patient through the hemodialyzer's blood compartment, while the dialysate solution flows countercurrent through the dialysate compartment. In this process, toxins and/or fluid are transferred across the membrane from the blood to the dialysate compartment. The hemodialysis delivery machine controls and monitors the parameters related to this processing, including the rate at which blood and dialysate are pumped through the system, and the rate at which fluid is removed from the patient. The high permeability hemodialysis system consists of the following devices

Registrar Corp assists High Permeability Hemodialysis System companies with:

  • FDA High Permeability Hemodialysis System Establishment Registration
  • FDA High Permeability Hemodialysis System Listing
  • FDA High Permeability Hemodialysis System Label Requirements and Exceptions
  • FDA High Permeability Hemodialysis System Import Information
  • FDA High Permeability Hemodialysis System Detentions (High Permeability Hemodialysis System Entry Refusals)
  • General U.S. Food and Drug Administration Medical Device Guidelines for:
       - High Permeability Hemodialysis System Manufacturers (High Permeability Hemodialysis System Suppliers)
       - High Permeability Hemodialysis System Distributors
       - High Permeability Hemodialysis System Processors
       - High Permeability Hemodialysis System Repackers
       - High Permeability Hemodialysis System Relabelers
       - High Permeability Hemodialysis System Exporters
       - High Permeability Hemodialysis System Importers
For more information about High Permeability Hemodialysis System Medical Devices, simply click below:




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U.S. FDA Regulations:

U.S. FDA 510(k) Regulation: 21 C.F.R. section 814.9.


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