510(k) K010737

SELECT CAP ARTERIAL CANNULA WITH PRESSURE MONITORING LINE, MODEL 78818,78820,78822,78824,78918,78920,78922,78924 by Medtronic Cardiac Surgical Products — Product Code DWF

K010737 is an FDA 510(k) premarket notification submitted by Medtronic Cardiac Surgical Products for the device "SELECT CAP ARTERIAL CANNULA WITH PRESSURE MONITORING LINE, MODEL 78818,78820,78822,78824,78918,78920,78922,78924". The FDA issued a decision of Substantially Equivalent on April 4, 2001. 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.