Tag: 510(k)

FFRangio system receives US FDA clearance

US FDA 510(k) clearance has been granted for the FFRangio System (CathWorks). The FFRangio system demonstrated accuracy versus the invasive FFR wire in a...

First patients treated in United States with OrbusNeich Teleport Microcatheter

The first patients in the United States have been treated using the OrbusNeich Teleport Microcatheter (Teleport; Cardiovascular Systems), which recently received US Food and...