SENSEI X ROBOTIC CATHETER SYSTEM

SENSEI X ROBOTIC CATHETER SYSTEM is an FDA 510(k)-cleared medical device (K141822) manufactured by Hanson 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 4, 2014. Regulation: 8.