510(k) K070286

BIO-CONSOLE, MODEL 560 by Medtronic — Product Code DWA

K070286 is an FDA 510(k) premarket notification submitted by Medtronic for the device "BIO-CONSOLE, MODEL 560". The FDA issued a decision of Substantially Equivalent on May 22, 2007. The device falls under product code DWA (Control, Pump Speed, Cardiopulmonary Bypass), a Class II device regulated under 21 CFR 870.4380. Medtronic has at least 10 other 510(k) clearances on record.