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U.S. FDA Medical Device Ureteral Catheter Adaptor Requirements

FDA Medical Device Definition: A urological catheter and accessories is a flexible tubular device that is inserted through the urethra and used to pass fluids to or from the urinary tract. This generic type of device includes radiopaque urological catheters, ureteral catheters, urethral catheters, coudecatheters, balloon retention type catheters, straight catheters, upper urinary tract catheters, double lumen female urethrographic catheters, disposable ureteral catheters, male urethrographic catheters, and urological catheter accessories including ureteral catheter stylets, ureteral catheter adapters, ureteral catheter holders, ureteral catheter stylets, ureteral catheterization trays, and the gastro-urological irrigation tray (for urological use).

Registrar Corp assists Ureteral Catheter Adaptor companies with:

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