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 Spectrum Medical , Ltd. and Livanova Deutschland, GmbH.
FDA 510(k) Cleared Controller, Temperature, Cardiopulmonary Bypass Devices (Product Code DWC)
About Product Code DWC - Regulatory Context
510(k) Submission Activity
30 total 510(k) submissions under product code DWC since 1981, with 30 receiving FDA clearance (average review time: 114 days).
Submission volume has declined in recent years - 0 submissions in the last 24 months compared to 1 in the prior period.
DWC devices are reviewed by the Cardiovascular panel. Browse all Cardiovascular devices →