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St. Jude Medical, Cardiac Rhythm Management Divisi

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
10
Inspections
0
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K122090SJM CONFIRM IMPLANTABLE CARDIAC MONITORNovember 15, 2012
K120296CPS DIRECT MEDIGUIDE ENABLED OUTER CATHETERMay 11, 2012
K120298CPS EXCEL MEDIGUIDE ENABLED GUIDEWIREMay 8, 2012
K111943AGILLS PF DELIVERY SYSTEMSeptember 29, 2011
K103250CPS DIRECT SL II SLITTABLE OUTER CATHETERJanuary 19, 2011
K093858PSA CABLE, MODELS 4160 AND 4161 AND PSA CABLE ADAPTER, MODEL 4053AApril 2, 2010
K092075CPS DIRECT SL II SLITTABLE OUTER CATHETER, MODELS DS2C001, DS2C002, DS2C003, DS2C004, DS2C005August 7, 2009
K090613CPS AIM SL SLITTABLE INNER CATHETERS, MODELS DS2N021-59, DS2N022-59, DS2NO23-59, DS2N024-65, DS2N024July 1, 2009
K080924MOND RVOT STYLET MODELS 4140, 4141, 4150, 4151April 30, 2008
K072864ST. JUDE MEDICAL, CPS DUO LEFT HEART LEAD DELIVERY SYSTEMMarch 13, 2008