510(k) K052524

BIO-MEDICUS MULTI-STAGE VENOUS FEMORAL PERCUTANEOUS KIT by Medtronic Perfusion Systems — Product Code DWF

K052524 is an FDA 510(k) premarket notification submitted by Medtronic Perfusion Systems for the device "BIO-MEDICUS MULTI-STAGE VENOUS FEMORAL PERCUTANEOUS KIT". The FDA issued a decision of Substantially Equivalent on November 22, 2005. 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.