510(k) K100646

AFFINITY PIXIE ARTERIAL FILTER WITH BALANCE BIOSURFACE by Medtronic, Inc. — Product Code DTM

K100646 is an FDA 510(k) premarket notification submitted by Medtronic, Inc. for the device "AFFINITY PIXIE ARTERIAL FILTER WITH BALANCE BIOSURFACE". The FDA issued a decision of Substantially Equivalent on December 16, 2010. The device falls under product code DTM (Filter, Blood, Cardiopulmonary Bypass, Arterial Line), a Class II device regulated under 21 CFR 870.4260. Medtronic, Inc. has at least 10 other 510(k) clearances on record.