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

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