BIO-MEDICUS MULTI-STAGE VENOUS FEMORAL PERCUTANEOUS KIT

About This 510(k) Submission

K052524 is an FDA 510(k) clearance for the BIO-MEDICUS MULTI-STAGE VENOUS FEMORAL PERCUTANEOUS KIT, 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 November 22, 2005, 69 days after receiving the submission on September 14, 2005. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.4210.