510(k) K163314

Guidezilla II Guide Extension Catheter; Guidezilla II LONG Guide Extension Catheter by Boston Scientific Corporation — Product Code DQY

K163314 is an FDA 510(k) premarket notification submitted by Boston Scientific Corporation for the device "Guidezilla II Guide Extension Catheter; Guidezilla II LONG Guide Extension Catheter". The FDA issued a decision of Substantially Equivalent on Mar 23, 2017. The device falls under product code DQY (Catheter, Percutaneous), a Class II device regulated under 21 CFR 870.1250. Boston Scientific Corporation has 238 other 510(k) clearances on record.