510(k) K131964

BIO-CONSOLE 560 EXTRACORPOREAL BLOOD PUMPING CONSOLE by Medtronic, Inc. — Product Code DWA

K131964 is an FDA 510(k) premarket notification submitted by Medtronic, Inc. for the device "BIO-CONSOLE 560 EXTRACORPOREAL BLOOD PUMPING CONSOLE". The FDA issued a decision of Substantially Equivalent on July 24, 2013. The device falls under product code DWA (Control, Pump Speed, Cardiopulmonary Bypass), a Class II device regulated under 21 CFR 870.4380. Medtronic, Inc. has at least 10 other 510(k) clearances on record.