510(k) K014195

KAYAK HYDROPHILIC GUIDE WIRES by Boston Scientific Corp — Product Code DOX

K014195 is an FDA 510(k) premarket notification submitted by Boston Scientific Corp for the device "KAYAK HYDROPHILIC GUIDE WIRES". The FDA issued a decision of Substantially Equivalent on March 19, 2002. The device falls under product code DOX (Fluorometer, Lead (Dedicated Instruments)), a Class II device regulated under 21 CFR 862.3550. Boston Scientific Corp has at least 10 other 510(k) clearances on record.