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U.S. FDA Medical Device Hemostat Requirements

FDA Medical Device Definition: An intravascular diagnostic catheter is a device used to record intracardiac pressures, to sample blood, and to introduce substances into the heart and vessels. Included in this generic device are right-heart catheters, left-heart catheters, and angiographic catheters, among others.

Registrar Corp assists Hemostat companies with:

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