FDA Product Code DWC: Controller, Temperature, Cardiopulmonary Bypass

If The Device Is Reusable, Validated Reprocessing Instructions And Reprocessing Validation Data For This Device Type Must Be Included In A 510(k) Submission (82 Fr 26807, Available At Https://www.gpo.gov/fdsys/pkg/fr-2017-06-09/pdf/2017-12007.pdf).

Leading manufacturers include Sorin Group Deutschland GmbH, Livanova Deutschland, GmbH and Gambro, Inc..