DWC · Class II · 21 CFR 870.4250

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.

30
Total
30
Cleared
114d
Avg days
1981
Since
30 devices
25–30 of 30
No devices found for this product code.