510(k) K090869

MIRCSP (MINIMALLY INVASIVE RETROGRADE CORONARY SINUS PERFUSION) MANUAL INFLATE CANNULA, MODEL 94113TD by Medtronic Perfusion Systems — Product Code DWF

K090869 is an FDA 510(k) premarket notification submitted by Medtronic Perfusion Systems for the device "MIRCSP (MINIMALLY INVASIVE RETROGRADE CORONARY SINUS PERFUSION) MANUAL INFLATE CANNULA, MODEL 94113TD". The FDA issued a decision of Substantially Equivalent on August 27, 2009. 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.