EOPA 3D ARTERIAL CANNULA, MODELS 78220,78222,78320,783222

About This 510(k) Submission

K061254 is an FDA 510(k) clearance for the EOPA 3D ARTERIAL CANNULA, MODELS 78220,78222,78320,783222, a Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass (Class II — Special Controls, product code DWF), submitted by Medtronic Perfusion Systems (Minneapolis, US). The FDA issued a Cleared decision on June 23, 2006, 50 days after receiving the submission on May 4, 2006. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.4210.