Device Dossier

GORE® DrySeal Flex Introducer Sheath - Vascular introducer kit

Device Dossier for GORE® DrySeal Flex Introducer Sheath - Vascular introducer kit (Vascular catheter introduction set, nonimplantable, Class III, sponsor…

Intended purpose

The GORE® DrySeal Flex Introducer Sheath is intended to be inserted in the vasculature to provide a conduit for the insertion of endovascular devices while minimizing blood loss associated with such insertions.

Functional description

The device consists of the introducer sheath tube for passage of endovascular tools, a hemostasis valve attached to the sheath tube to minimize bleeding through the sheath during the procedure, and a dilator with a tapered leading end which inserts through the sheath and valve assembly to provide a smooth transition of the wire to the dilator and the dilator to the sheath while advancing the introducer sheath assembly into the patient’s vasculature system.

TGA Public Summary