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U.S. FDA Medical Device Cannula Clamp Requirements

FDA Medical Device Definition: A blood access device and accessories is a device intended to provide access to a patient's blood for hemodialysis or other chronic uses. When used in hemodialysis, it is part of an artificial kidney system for the treatment of patients with renal failure or toxemic conditions and provides access to a patient's blood for hemodialysis. The device includes implanted blood access devices, nonimplanted blood access devices, and accessories for both the implanted and nonimplanted blood access devices.

Registrar Corp assists Cannula Clamp companies with:

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