Controller, Temperature, Cardiopulmonary Bypass

DWC is the FDA product code for Controller, Temperature, Cardiopulmonary Bypass, a class II device type, regulated under 21 CFR 870.4250. FDA's definition for this code reads: "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)". As of 2026-09-10, FDA records hold 30 510(k) clearances under this code, the most recent dated 2022-11-16, and 52 recalls.