510(k) K003535

STYLET KIT, MODELS 6254,6282,6293 by Medtronic Vascular — Product Code DRB

K003535 is an FDA 510(k) premarket notification submitted by Medtronic Vascular for the device "STYLET KIT, MODELS 6254,6282,6293". The FDA issued a decision of Substantially Equivalent on February 8, 2001. The device falls under product code DRB (Stylet, Catheter), a Class II device regulated under 21 CFR 870.1380. Medtronic Vascular has at least 10 other 510(k) clearances on record.