510(k) K201834

HI-TORQUE PROCEED Guide Wire Family by Abbott Vascular — Product Code DQX

K201834 is an FDA 510(k) premarket notification submitted by Abbott Vascular for the device "HI-TORQUE PROCEED Guide Wire Family". The FDA issued a decision of Substantially Equivalent on July 30, 2020. 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.