Device Dossier

Edwards eSheath Introducer Set - Vascular introducer kit

Device Dossier for Edwards eSheath Introducer Set - Vascular introducer kit (Vascular catheter introduction set, nonimplantable, Class III, sponsor…

Intended purpose

The Edwards eSheath Introducer Set is intended for introduction of interventional devices into the vascular system. The product is intended for use by physicians trained and experienced in interventional techniques. Standard techniques for placement of vascular access sheaths should be employed.

Functional description

The Edwards eSheath Introducer Set is an expandable sheath (eSheath) that provides access into the target vessel while maintaining hemostasis and temporarily enlarges its diameter to allow for passage of a device.

TGA Public Summary