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