510(k) K171948

Roadrunner Extra Support Wire Guide by Cook Incorporated — Product Code DQX

K171948 is an FDA 510(k) premarket notification submitted by Cook Incorporated for the device "Roadrunner Extra Support Wire Guide". The FDA issued a decision of Substantially Equivalent on Jan 5, 2018. The device falls under product code DQX (Wire, Guide, Catheter), a Class II device regulated under 21 CFR 870.1330. Cook Incorporated has 174 other 510(k) clearances on record.