510(k) K994171

MEDTRONIC AORTOCORONARY SHUNT AND SEPARATELY PACKAGED ARTERIOTOMY CANNULAE by Medtronic Cardiac Surgical Products — Product Code DWF

K994171 is an FDA 510(k) premarket notification submitted by Medtronic Cardiac Surgical Products for the device "MEDTRONIC AORTOCORONARY SHUNT AND SEPARATELY PACKAGED ARTERIOTOMY CANNULAE". The FDA issued a decision of Substantially Equivalent on April 27, 2000. 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 Cardiac Surgical Products has at least 6 other 510(k) clearances on record.