Device Dossier

Adelante peel away introducer system - model number AP0716GW2-BX5 - Vascular introducer kit

Device Dossier for Adelante peel away introducer system - model number AP0716GW2-BX5 - Vascular introducer kit (Vascular catheter introduction set,…

Intended purpose

The Adelante Peel Away Introducer System is intended for the introduction of pacing leads or catheters into the body. It is sterile and single use.

Functional description

The Adelante Peel Away Introducer System consists of an introducer sheath and a dilator. The introducer system also includes 2 guidewires, a J-straightener, a needle, and a syringe. The sheath tube has a hydrophobic coating and a tapered tip. The sheath material is manufactured with radiopaque material that allows visualisation under fluoroscopy.

TGA Public Summary