Tag: 510k clearance
Surmodics receives FDA 510(k) clearance for Sublime radial access 0.014 RX...
Surmodics recently announced it has received US Food and Drug Administration (FDA) 510(k) clearance for its Sublime radial access 0.014 rapid exchange (RX) percutaneous...
Update on regulatory landscape points to benefits of global collaboration
At the 2019 Vascular Interventional Advances (VIVA) conference in Las Vegas, USA (4–7 November), Misti Malone (US Food and Drug Administration Office for...
Rex Medical receives 510k clearance for Revolution Peripheral Atherectomy System
Rex Medical recently announced that it has received 510k clearance from the US Food and Drug Administration (FDA) for the Revolution Peripheral Atherectomy System.
Regulatory...
