510(k) K981326

LAKE REGION MANUFACTURING GUIDEWIRES by Lake Region Mfg., Inc. — Product Code DQX

K981326 is an FDA 510(k) premarket notification submitted by Lake Region Mfg., Inc. for the device "LAKE REGION MANUFACTURING GUIDEWIRES". The FDA issued a decision of Substantially Equivalent on July 10, 1998. 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.