Medtronic Temporary External Pacemaker 53401

Medtronic Temporary External Pacemaker 53401 is an FDA 510(k)-cleared medical device (K162054) manufactured by Medtronic, 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 October 17, 2016. Regulation: 8.