510(k) K060454

TITAN GUIDEWIRE by Lake Region Mfg., Inc. — Product Code DQX

K060454 is an FDA 510(k) premarket notification submitted by Lake Region Mfg., Inc. for the device "TITAN GUIDEWIRE". The FDA issued a decision of Substantially Equivalent on March 24, 2006. The device falls under product code DQX (Wire, Guide, Catheter), a Class II device regulated under 21 CFR 870.1330. Lake Region Mfg., Inc. has at least 10 other 510(k) clearances on record.