510(k) K182985

Roadrunner PC Wire Guide, Olcott Torque Device by Cook Incorporated — Product Code DQX

K182985 is an FDA 510(k) premarket notification submitted by Cook Incorporated for the device "Roadrunner PC Wire Guide, Olcott Torque Device". The FDA issued a decision of Substantially Equivalent on July 22, 2019. The device falls under product code DQX (Wire, Guide, Catheter), a Class II device regulated under 21 CFR 870.1330. Cook Incorporated has at least 10 other 510(k) clearances on record.