Device Dossier

Peel-Away Introducer - Catheter, intravascular, guiding

Device Dossier for Peel-Away Introducer - Catheter, intravascular, guiding (Catheter, intravascular, guiding, Class III, sponsor Abbott Medical). ARTG…

Intended purpose

To provide a transvenous conduit for the introduction of cardiac leads and catheters into the venous vascular system.

Functional description

The Peel-Away introducer sheath is the outer component, and the dilator fits inside the sheath with the distal end protruding out. The assembled sheath/dilator combination is advanced over the guidewire into the vessel. At the proximal end of the sheath is a t-handle hub designed to split and facilitate peeling action of the scored sheath tubing.

TGA Public Summary