510(k) K061254

EOPA 3D ARTERIAL CANNULA, MODELS 78220,78222,78320,783222 by Medtronic Perfusion Systems — Product Code DWF

K061254 is an FDA 510(k) premarket notification submitted by Medtronic Perfusion Systems for the device "EOPA 3D ARTERIAL CANNULA, MODELS 78220,78222,78320,783222". The FDA issued a decision of Substantially Equivalent on June 23, 2006. 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.