510(k) K253746

Enroute 0.014'' Transcarotid Guidewire by Lake Region Medical — Product Code DQX

K253746 is an FDA 510(k) premarket notification submitted by Lake Region Medical for the device "Enroute 0.014'' Transcarotid Guidewire". The FDA issued a decision of Substantially Equivalent on March 19, 2026. 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.