510(k) K152404

Hi-Torque Command 18 Guide Wire by Abbott Vascular — Product Code DQX

K152404 is an FDA 510(k) premarket notification submitted by Abbott Vascular for the device "Hi-Torque Command 18 Guide Wire". The FDA issued a decision of Substantially Equivalent on September 21, 2015. The device falls under product code DQX (Wire, Guide, Catheter), a Class II device regulated under 21 CFR 870.1330. Abbott Vascular has at least 10 other 510(k) clearances on record.