510(k) K182457

Hi-Torque Vektor, .014, 195cm, Str, Hi-Torque Vektor, .014, 195cm, J, Hi-Torque Vektor, .014, 300cm, Str, Hi-Torque Vektor, .014, 300cm, J by Brivant Limited (Lake Region Medical) — Product Code DQX

K182457 is an FDA 510(k) premarket notification submitted by Brivant Limited (Lake Region Medical) for the device "Hi-Torque Vektor, .014, 195cm, Str, Hi-Torque Vektor, .014, 195cm, J, Hi-Torque Vektor, .014, 300cm, Str, Hi-Torque Vektor, .014, 300cm, J". The FDA issued a decision of Substantially Equivalent on Apr 18, 2019. The device falls under product code DQX (Wire, Guide, Catheter), a Class II device regulated under 21 CFR 870.1330.