510(k) K120296

CPS DIRECT MEDIGUIDE ENABLED OUTER CATHETER by St. Jude Medical, Cardiac Rhythm Management Divisi — Product Code DQY

K120296 is an FDA 510(k) premarket notification submitted by St. Jude Medical, Cardiac Rhythm Management Divisi for the device "CPS DIRECT MEDIGUIDE ENABLED OUTER CATHETER". The FDA issued a decision of Substantially Equivalent on May 11, 2012. The device falls under product code DQY (Catheter, Percutaneous), a Class II device regulated under 21 CFR 870.1250. St. Jude Medical, Cardiac Rhythm Management Divisi has at least 9 other 510(k) clearances on record.