Pantheris Catheter (8Fr), Pantheris Catheter (7Fr)

Pantheris Catheter (8Fr), Pantheris Catheter (7Fr) is an FDA 510(k)-cleared medical device (K153460) manufactured by Avinger, Inc.. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on February 29, 2016. Regulation: 8.