510(k) K033264

MALLEABLE SINGLE STAGE VENOUS CANNULA WITH CARMEDA BIOACTIVE SURFACE, MODEL CB681XX SERIES by Medtronic Perfusion Systems — Product Code DWF

K033264 is an FDA 510(k) premarket notification submitted by Medtronic Perfusion Systems for the device "MALLEABLE SINGLE STAGE VENOUS CANNULA WITH CARMEDA BIOACTIVE SURFACE, MODEL CB681XX SERIES". The FDA issued a decision of Substantially Equivalent on October 31, 2003. The device falls under product code DWF (Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass), a Class II device regulated under 21 CFR 870.4210. Medtronic Perfusion Systems has at least 10 other 510(k) clearances on record.