EOPA ELONGATED ONE-PIECE ARTERIAL CANNULA AND GUIDEWIRE

About This 510(k) Submission

K031037 is an FDA 510(k) clearance for the EOPA ELONGATED ONE-PIECE ARTERIAL CANNULA AND GUIDEWIRE, 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 May 13, 2003, 42 days after receiving the submission on April 1, 2003. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.4210.