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…
- GMDN category: Vascular catheter introduction set, nonimplantable
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.