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U.S. FDA Medical Device Infusion Catheter Requirements

FDA Medical Device Definition: An introduction/drainage catheter is a device that is a flexible single or multilumen tube intended to be used to introduce nondrug fluids into body cavities other than blood vessels, drain fluids from body cavities, or evaluate certain physiologic conditions. Examples include irrigation and drainage catheters, pediatric catheters, peritoneal catheters (including dialysis), and other general surgical catheters. An introduction/drainage catheter accessory is intended to aid in the manipulation of or insertion of the device into the body. Examples of accessories include adaptors, connectors, and catheter needles.

Registrar Corp assists Infusion Catheter companies with:

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

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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