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U.S. FDA Medical Device Catheter Dilator 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 Catheter Dilator companies with:

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