Tag: 510(k)

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...

BTG receives FDA 510(k) clearance for EKOS Control Unit 4.0

BTG has announced US Food and Drug Administration (FDA) 510(k) clearance has been granted to the EKOS Control Unit 4.0. The EKOS system includes an ultrasonic...

Merit Medical receives 510(k) clearance for the SwiftNINJA steerable microcatheter

Merit Medical Systems has received 510(k) clearance for the SwiftNINJA steerable microcatheter, covering peripheral and coronary applications. With the exception of Japan, Merit has...