Hansen Medical Magellan Robotic Catheter 6Fr and Accessory Components

Hansen Medical Magellan Robotic Catheter 6Fr and Accessory Components is an FDA 510(k)-cleared medical device (K151463) 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 August 17, 2015. Regulation: 8.