Registrar Corp

HomeMedical DevicesRegistration & Medical Device ListingsMedical Device Samples › U.S. FDA Punch Catheter Instrument Regulations

U.S. FDA Medical Device Punch Catheter Instrument Requirements


FDA Medical Device Definition: A suprapubic urological catheter and accessories is a flexible tubular device that is inserted through the abdominal wall into the urinary bladder with the aid of a trocar and cannula. The device is used to pass fluids to and from the urinary tract. This generic type of device includes the suprapubic catheter and tube, Malecot catheter, catheter punch instrument, suprapubic drainage tube, and the suprapubic cannula and trocar.

Registrar Corp assists Punch Catheter Instrument companies with:

  • FDA Punch Catheter Instrument Establishment Registration
  • FDA Punch Catheter Instrument Listing
  • FDA Punch Catheter Instrument Label Requirements and Exceptions
  • FDA Punch Catheter Instrument Import Information
  • FDA Punch Catheter Instrument Detentions (Punch Catheter Instrument Entry Refusals)
  • General U.S. Food and Drug Administration Medical Device Guidelines for:
       - Punch Catheter Instrument Manufacturers (Punch Catheter Instrument Suppliers)
       - Punch Catheter Instrument Distributors
       - Punch Catheter Instrument Processors
       - Punch Catheter Instrument Repackers
       - Punch Catheter Instrument Relabelers
       - Punch Catheter Instrument Exporters
       - Punch Catheter Instrument Importers
For more information about Punch Catheter Instrument 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.
Home | About Us | News | Resources | Exhibitions | Seminars | Associations | Careers | Sitemap | Terms of Use © 2016 Registrar Corp
 
Food and Beverages | Drugs | Cosmetics | Medical Devices | Radiation-Emitting Electronic Devices | Color Additives | Tobacco