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

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