DWC

Controller, Temperature, Cardiopulmonary Bypass

Product code

DWC

Device name

Controller, Temperature, Cardiopulmonary Bypass

Device class

Class 2

21 CFR

21 CFR 870.4250

Medical specialty

Cardiovascular

Marketing pathway

510(K)

Flag

Life-sustaining / life-supporting

510(k) clearances (all years, FDA)

30 (all years; only the last 3 years are listed here)

FDA classification definition

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).

Definition text from the FDA device classification database (U.S. federal government work, public domain).