510(k) K091582

GTX GUIDEWIRE, MODELS TBD-GTX 1, 3,6,9,12, 15 by Medtronic Vascular — Product Code DQX

K091582 is an FDA 510(k) premarket notification submitted by Medtronic Vascular for the device "GTX GUIDEWIRE, MODELS TBD-GTX 1, 3,6,9,12, 15". The FDA issued a decision of Substantially Equivalent on December 4, 2009. The device falls under product code DQX (Wire, Guide, Catheter), a Class II device regulated under 21 CFR 870.1330. Medtronic Vascular has at least 10 other 510(k) clearances on record.