Magellan Robotic System, Magellan Robotic Catheter 10Fr

Magellan Robotic System, Magellan Robotic Catheter 10Fr is an FDA 510(k)-cleared medical device (K143227) manufactured by Hansen Medical, 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 June 30, 2015. Regulation: 8.