510(k) K071253

AFFINITY PEDIATRIC ARTERIAL FILTER, MODEL S4014 AND WITH CARMEDA BIOACTIVE SURFACE, MODEL CB4014 by Medtronic Vascular — Product Code DTM

K071253 is an FDA 510(k) premarket notification submitted by Medtronic Vascular for the device "AFFINITY PEDIATRIC ARTERIAL FILTER, MODEL S4014 AND WITH CARMEDA BIOACTIVE SURFACE, MODEL CB4014". The FDA issued a decision of Substantially Equivalent on July 3, 2007. The device falls under product code DTM (Filter, Blood, Cardiopulmonary Bypass, Arterial Line), a Class II device regulated under 21 CFR 870.4260. Medtronic Vascular has at least 10 other 510(k) clearances on record.