MALLEABLE SINGLE STAGE VENOUS CANNULA WITH CARMEDA BIOACTIVE SURFACE, MODEL CB681XX SERIES

About This 510(k) Submission

K033264 is an FDA 510(k) clearance for the MALLEABLE SINGLE STAGE VENOUS CANNULA WITH CARMEDA BIOACTIVE SURFACE, MODEL CB681XX SERIES, 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 October 31, 2003, 22 days after receiving the submission on October 9, 2003. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.4210.