510(k) K010906

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

K010906 is an FDA 510(k) premarket notification submitted by Medtronic Vascular for the device "MEDTRONIC STYLET KIT, MODELS 6282, 6293, AND 6254". The FDA issued a decision of Substantially Equivalent on April 5, 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.