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U.S. FDA Medical Device Dialysis Arm 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 Dialysis Arm Clamp companies with:

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