Guidezilla II Guide Extension Catheter; Guidezilla II LONG Guide Extension Catheter

Guidezilla II Guide Extension Catheter; Guidezilla II LONG Guide Extension Catheter is an FDA 510(k)-cleared medical device (K163314) manufactured by Boston Scientific Corporation. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on March 22, 2017. Regulation: 8.