510(k) K141233

AFFINITY PIXIE OXYGENATION SYSTEM WITH; CARMEDA BIOACTIVE SURFACE, BALANCE BIOSUFACE by Medtronic, Inc. — Product Code DTN

K141233 is an FDA 510(k) premarket notification submitted by Medtronic, Inc. for the device "AFFINITY PIXIE OXYGENATION SYSTEM WITH; CARMEDA BIOACTIVE SURFACE, BALANCE BIOSUFACE". The FDA issued a decision of Substantially Equivalent on June 12, 2014. The device falls under product code DTN (Reservoir, Blood, Cardiopulmonary Bypass), a Class II device regulated under 21 CFR 870.4400. Medtronic, Inc. has at least 10 other 510(k) clearances on record.