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..
FDA 510(k) Cleared Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass Devices (Product Code DWF)
About Product Code DWF - Regulatory Context
510(k) Submission Activity
401 total 510(k) submissions under product code DWF since 1977, with 401 receiving FDA clearance (average review time: 111 days).
Submission volume has increased in recent years - 11 submissions in the last 24 months compared to 6 in the prior period - suggesting growing market activity in this device classification.
FDA Review Time
FDA review times for DWF submissions have been consistent, averaging 103 days recently vs 112 days historically.
DWF devices are reviewed by the Cardiovascular panel. Browse all Cardiovascular devices →