510(k) for Bio-Vascular's intraluminal shunt:
This article was originally published in Clinica
Executive Summary
Bio-Vascular has received 510(k) clearance from the FDA to market its Flo-Thru intraluminal shunt. Used in coronary and peripheral bypass procedures, the disposable device is designed to divert blood flow during the suturing of blood vessels. It helps surgeons by providing a blood-free stented operating site and is removed just before the final suturing of the vessel. The company of St Paul, Minnesota, expects to begin shipping within the next two months.