510(k) K080924

MOND RVOT STYLET MODELS 4140, 4141, 4150, 4151 by St. Jude Medical, Cardiac Rhythm Management Divisi — Product Code DRB

K080924 is an FDA 510(k) premarket notification submitted by St. Jude Medical, Cardiac Rhythm Management Divisi for the device "MOND RVOT STYLET MODELS 4140, 4141, 4150, 4151". The FDA issued a decision of Substantially Equivalent on April 30, 2008. The device falls under product code DRB (Stylet, Catheter), a Class II device regulated under 21 CFR 870.1380. St. Jude Medical, Cardiac Rhythm Management Divisi has at least 9 other 510(k) clearances on record.