510(k) K981667

HYDROPHILIC COATED GUIDEWIRE by Lake Region Mfg., Inc. — Product Code KNY

K981667 is an FDA 510(k) premarket notification submitted by Lake Region Mfg., Inc. for the device "HYDROPHILIC COATED GUIDEWIRE". The FDA issued a decision of Substantially Equivalent on June 5, 1998. The device falls under product code KNY (Accessories, Catheter, G-U), a Class II device regulated under 21 CFR 876.5130. Lake Region Mfg., Inc. has at least 10 other 510(k) clearances on record.