510(k) K040173

PEDIATRIC AORTIC ROOT CANNULA by Medtronic Perfusion Systems — Product Code DWF

K040173 is an FDA 510(k) premarket notification submitted by Medtronic Perfusion Systems for the device "PEDIATRIC AORTIC ROOT CANNULA". The FDA issued a decision of Substantially Equivalent on March 19, 2004. 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.