510(k) K171897

Approach CTO Microwire Guide by Cook Incorporated — Product Code DQX

K171897 is an FDA 510(k) premarket notification submitted by Cook Incorporated for the device "Approach CTO Microwire Guide". The FDA issued a decision of Substantially Equivalent on Aug 21, 2017. 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.