Hansen Medical Magellan Robotic Catheter eKit

Hansen Medical Magellan Robotic Catheter eKit is an FDA 510(k)-cleared medical device (K153304) 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 January 31, 2016. Regulation: 8.