510(k) K133155

HYDROPHILIC COATED GUIDEWIRE by Lake Region Medical — Product Code DQX

K133155 is an FDA 510(k) premarket notification submitted by Lake Region Medical for the device "HYDROPHILIC COATED GUIDEWIRE". The FDA issued a decision of Substantially Equivalent on April 7, 2014. 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.