510(k) K092075

CPS DIRECT SL II SLITTABLE OUTER CATHETER, MODELS DS2C001, DS2C002, DS2C003, DS2C004, DS2C005 by St. Jude Medical, Cardiac Rhythm Management Divisi — Product Code DQY

K092075 is an FDA 510(k) premarket notification submitted by St. Jude Medical, Cardiac Rhythm Management Divisi for the device "CPS DIRECT SL II SLITTABLE OUTER CATHETER, MODELS DS2C001, DS2C002, DS2C003, DS2C004, DS2C005". The FDA issued a decision of Substantially Equivalent on August 7, 2009. 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.