510(k) K160643

ENROUTE 0.014 Guidewire by Lake Region Medical — Product Code DQX

K160643 is an FDA 510(k) premarket notification submitted by Lake Region Medical for the device "ENROUTE 0.014 Guidewire". The FDA issued a decision of Substantially Equivalent on October 18, 2016. The device falls under product code DQX (Wire, Guide, Catheter), a Class II device regulated under 21 CFR 870.1330. Lake Region Medical has at least 10 other 510(k) clearances on record.