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U.S. FDA Medical Device Balloon Type 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 Balloon Type Catheter companies with:

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