510(k) K033416

SELECT 3D ARTERIAL CANNULA WITH CARMEDA BIOACTIVE SURFACE AND SELECT CAP ARTERIAL CANNULA WITH CARMEDA BIOACTIVE SURFACE by Medtronic Perfusion Systems — Product Code DWF

K033416 is an FDA 510(k) premarket notification submitted by Medtronic Perfusion Systems for the device "SELECT 3D ARTERIAL CANNULA WITH CARMEDA BIOACTIVE SURFACE AND SELECT CAP ARTERIAL CANNULA WITH CARMEDA BIOACTIVE SURFACE". The FDA issued a decision of Substantially Equivalent on November 5, 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.