510(k) K181353

Lunderquist® Fixed Core Wire Guide by Cook Incorporated — Product Code DQX

K181353 is an FDA 510(k) premarket notification submitted by Cook Incorporated for the device "Lunderquist® Fixed Core Wire Guide". The FDA issued a decision of Substantially Equivalent on Feb 15, 2019. 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.