Device Dossier

SafeSheath II - Vascular introducer kit

Device Dossier for SafeSheath II - Vascular introducer kit (Vascular catheter introduction set, nonimplantable, Class III, sponsor Medtronic). ARTG…

Intended purpose

For the introduction of various types of pacing leads and catheters.

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 with or without snap-fit dilator.

TGA Public Summary