510(k) K013013

MEDTRONIC DLP ARTERIAL CANNULA WITH 3D TIP - 22 FR. by Medtronic Cardiac Surgical Products — Product Code DWF

K013013 is an FDA 510(k) premarket notification submitted by Medtronic Cardiac Surgical Products for the device "MEDTRONIC DLP ARTERIAL CANNULA WITH 3D TIP - 22 FR.". The FDA issued a decision of Substantially Equivalent on December 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.