510(k) K090163

STYLET, MODELS 4060, 4062, 4064, 4090, 4091 AND 4078 by St Jude Medical — Product Code DRB

K090163 is an FDA 510(k) premarket notification submitted by St Jude Medical for the device "STYLET, MODELS 4060, 4062, 4064, 4090, 4091 AND 4078". The FDA issued a decision of Substantially Equivalent on April 1, 2009. The device falls under product code DRB (Stylet, Catheter), a Class II device regulated under 21 CFR 870.1380. St Jude Medical has at least 10 other 510(k) clearances on record.