Tag: 510 K
US FDA clears CorPath GRX system for use in peripheral vascular...
Corindus has announced receiving 510(k) clearance from the US Food and Drug Administration (FDA) for use of the CorPath GRX system in peripheral vascular...
BTG receives US FDA 510(k) clearance for Ekos control unit 4.0
BTG has announced that US FDA 510(k) clearance has been granted to the Ekos control unit 4.0.
The Ekos system includes an ultrasonic device...
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 global...
