Device Dossier

Heartspan Steerable Sheath Introducer Kit - Vascular introducer kit

Device Dossier for Heartspan Steerable Sheath Introducer Kit - Vascular introducer kit (Vascular catheter introduction set, nonimplantable, Class III,…

Intended purpose

The HeartSpan Steerable Introducer is indicated for introduction of various cardiovascular catheters into the heart, including the left side of the heart through the interatrial septum.

Functional description

This device consist of a dilator, guide wire, and steerable sheath, which are designed for catheter introduction into the cardiac anatomy. The steerable introducer contains a hemostasis valve, and a sideport with three-way stopcock. The introducer handle includes a rotating knob to enable tip deflection. The steerable introducer also includes an atraumatic soft tip, and a lubricious coating. The dilator is designed to conform to the inner diameter of the sheath, and has a tapered tip.

TGA Public Summary