Device Dossier

Adelante SafeSheath II Hemostatic Introducer System - Vascular introducer kit

Device Dossier for Adelante SafeSheath II Hemostatic Introducer System - Vascular introducer kit (Vascular catheter introduction set, nonimplantable,…

Intended purpose

The Adelante SafeSheath II Hemostatic Introducer System for Vascular Access is intended for the introduction of various types of pacing leads and catheters. It is a sterile, single use device.

Functional description

SafeSheath II is a haemostatic peel-away introducer system for vascular access. It has a low insertion/withdrawal force lubricated valve, ergonomically-designed, easy-splitting hub, extruded score line sheath, infusion side port and snap-fit dilator.

TGA Public Summary