510(k) K113235

PRESSURE DISPLAY BOX,DLP DISPOSABLE PRESSURE DISPLAY SETS-NON STERILE VERSIONS by Medtronic, Inc. — Product Code DXS

K113235 is an FDA 510(k) premarket notification submitted by Medtronic, Inc. for the device "PRESSURE DISPLAY BOX,DLP DISPOSABLE PRESSURE DISPLAY SETS-NON STERILE VERSIONS". The FDA issued a decision of Substantially Equivalent on December 2, 2011. The device falls under product code DXS (Gauge, Pressure, Coronary, Cardiopulmonary Bypass), a Class II device regulated under 21 CFR 870.4310. Medtronic, Inc. has at least 10 other 510(k) clearances on record.