FDA Product Code DWF: Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass

Under FDA product code DWF, vascular catheters, cannulas, and tubing for cardiopulmonary bypass are cleared for use during open-heart surgery.

These components form the extracorporeal circuit that drains venous blood to the heart-lung machine and returns oxygenated blood to the arterial system during cardiopulmonary bypass. They must withstand the mechanical stresses and flow conditions of bypass while maintaining biocompatibility.

DWF devices are Class II medical devices, regulated under 21 CFR 870.4210 and reviewed by the FDA Cardiovascular panel.

Leading manufacturers include Medtronic, Inc., C.R. Bard, Inc. and Medtronic Vascular.