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U.S. FDA Medical Device Cardiopulmonary Blood Filter Requirements: Cardiopulmonary Blood Filter

FDA Medical Device Definition: A cardiopulmonary bypass arterial line blood filter is a device used as part of a gas exchange (oxygenator) system to filter nonbiologic particles and emboli (blood clots or pieces of foreign material flowing in the bloodstream which will obstruct circulation by blocking a vessel) out of the blood. It is used in the arterial return line

Registrar Corp assists Cardiopulmonary Blood Filter companies with:

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




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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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