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., Sorin Group Italia S.R.L. and AngioDynamics, Inc..
List of Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass devices cleared through 510(k)
How to use this database
This page lists all FDA 510(k) submissions for Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass devices (product code DWF). Click any device to view full submission details, including the decision date, manufacturer information, predicate device, and a link to the official FDA record.
These devices fall under the Cardiovascular FDA review panel. Browse all Cardiovascular devices →