510(k) K182315

Magic Torque DLVR Guidewire by Boston Scientific Corporation — Product Code DQX

K182315 is an FDA 510(k) premarket notification submitted by Boston Scientific Corporation for the device "Magic Torque DLVR Guidewire". The FDA issued a decision of Substantially Equivalent on Sep 26, 2018. The device falls under product code DQX (Wire, Guide, Catheter), a Class II device regulated under 21 CFR 870.1330. Boston Scientific Corporation has 238 other 510(k) clearances on record.