510(k) K142393

PREDICATE III GUIDEWIRE by Lake Region Medical — Product Code DQX

K142393 is an FDA 510(k) premarket notification submitted by Lake Region Medical for the device "PREDICATE III GUIDEWIRE". The FDA issued a decision of Substantially Equivalent on November 25, 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.