Device Dossier

Guidezilla II LONG Guide Extension Catheter - Catheter, intravascular, guiding

Device Dossier for Guidezilla II LONG Guide Extension Catheter - Catheter, intravascular, guiding (Catheter, intravascular, guiding, Class III, sponsor…

Intended purpose

The Guidezilla II LONG Guide Extension Catheter is intended to be used in conjunction with guide catheters to access discrete regions of the coronary and/or peripheral vasculature, and to facilitate placement of interventional devices.

Functional description

The Guidezilla II Guide Extension Catheter is a single-lumen rapid exchange catheter designed to act as an extension to a traditional guide catheter and facilitate the delivery of interventional devices into the vasculature. The device consists of a hydrophilic-coated, single-lumen distal guide segment connected to a stainless steel proximal hypotube.

TGA Public Summary