Device Dossier

Aveir Introducers - Vascular introducer kit

Device Dossier for Aveir Introducers - Vascular introducer kit (Vascular catheter introduction set, nonimplantable, Class III, sponsor Abbott Medical).…

Intended purpose

The Aveir Introducer is intended to provide a conduit into the venous system for insertion of diagnostic and other interventional devices through percutaneous insertion over a guidewire, its haemostasis valve to minimise air introduction and maintain haemostasis during insertion and/or exchange, and its connection to a dilator for a smooth introducer tip transition and retention to prevent vessel trauma.

Functional description

The Aveir Introducer comprises of an introducer sheath and dilator. The introducer sheath is fitted with an haemostasis valve to minimise air introduction and maintain haemostasis during insertion and/or exchange, a sideport with a three-way stopcock and a suture loop. The device is also supplied with a dilator and contains a locking mechanism that locks the dilator into the introducer sheath.

TGA Public Summary