510(k) K130766

ROADRUNNER UNIGLIDE HYDROPHILIC WIRE GUIDE by Cook, Inc. — Product Code DQX

K130766 is an FDA 510(k) premarket notification submitted by Cook, Inc. for the device "ROADRUNNER UNIGLIDE HYDROPHILIC WIRE GUIDE". The FDA issued a decision of Substantially Equivalent on July 17, 2013. The device falls under product code DQX (Wire, Guide, Catheter), a Class II device regulated under 21 CFR 870.1330. Cook, Inc. has at least 10 other 510(k) clearances on record.