AFFINITY PEDIATRIC ARTERIAL FILTER, MODEL S4014 AND WITH CARMEDA BIOACTIVE SURFACE, MODEL CB4014

About This 510(k) Submission

K071253 is an FDA 510(k) clearance for the AFFINITY PEDIATRIC ARTERIAL FILTER, MODEL S4014 AND WITH CARMEDA BIOACTIVE SURFACE, MODEL CB4014, a Filter, Blood, Cardiopulmonary Bypass, Arterial Line (Class II — Special Controls, product code DTM), submitted by Medtronic Vascular (Minneapolis, US). The FDA issued a Cleared decision on July 3, 2007, 60 days after receiving the submission on May 4, 2007. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.4260.