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U.S. FDA Medical Device Multiple Lumen 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 Multiple Lumen Catheter companies with:

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