ULTRAFLEX VENOUS CANNULA, MODEL 970XX AND CB970XX

About This 510(k) Submission

K031827 is an FDA 510(k) clearance for the ULTRAFLEX VENOUS CANNULA, MODEL 970XX AND CB970XX, 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 July 2, 2003, 19 days after receiving the submission on June 13, 2003. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.4210.