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U.S. FDA Medical Device Intravascular Infusion Port and Catheter Requirements: Intravascular Infusion Port and Catheter

FDA Medical Device Definition: A subcutaneous, implanted, intravascular infusion port and catheter is a device that consists of a subcutaneous, implanted reservoir that connects to a long-term intravascular catheter. The device allows for repeated access to the vascular system for the infusion of fluids and medications and the sampling of blood. The device consists of a portal body with a resealable septum and outlet made of metal, plastic, or combination of these materials and a long-term intravascular catheter is either preattached to the port or attached to the port at the time of device placement. The device is available in various profiles and sizes and can be of a single or multiple lumen design

Registrar Corp assists Intravascular Infusion Port and Catheter companies with:

  • FDA Intravascular Infusion Port and Catheter Establishment Registration
  • FDA Intravascular Infusion Port and Catheter Listing
  • FDA Intravascular Infusion Port and Catheter Label Requirements and Exceptions
  • FDA Intravascular Infusion Port and Catheter Import Information
  • FDA Intravascular Infusion Port and Catheter Detentions (Intravascular Infusion Port and Catheter Entry Refusals)
  • General U.S. Food and Drug Administration Medical Device Guidelines for:
       - Intravascular Infusion Port and Catheter Manufacturers (Intravascular Infusion Port and Catheter Suppliers)
       - Intravascular Infusion Port and Catheter Distributors
       - Intravascular Infusion Port and Catheter Processors
       - Intravascular Infusion Port and Catheter Repackers
       - Intravascular Infusion Port and Catheter Relabelers
       - Intravascular Infusion Port and Catheter Exporters
       - Intravascular Infusion Port and Catheter Importers
For more information about Intravascular Infusion Port and Catheter 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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