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U.S. FDA Medical Device Long-Term Intravascular Catheter Requirements: Long-Term Intravascular Catheter

FDA Medical Device Definition: A percutaneous, implanted, long-term intravascular catheter is a device that consists of a slender tube and any necessary connecting fittings, such as luer hubs, and accessories that facilitate the placement of the device. The device allows for repeated access to the vascular system for long-term use of 30 days or more, and it is intended for administration of fluids, medications, and nutrients; the sampling of blood; and monitoring blood pressure and temperature. The device may be constructed of metal, rubber, plastic, composite materials, or any combination of these materials and may be of single or multiple lumen design

Registrar Corp assists Long-Term Intravascular Catheter companies with:

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


Registrar Corp assists businesses with U.S. FDA compliance. Certificates of Registration issued by Registrar Corp provide confirmation to industry that you are fulfilling U.S. FDA registration requirements. U.S. FDA does not issue or recognize Certificates of Registration. Registrar Corp is not affiliated with the U.S. Food and Drug Administration.
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