MEDTRONIC MODEL 5318 TEMPORARY PACEMAKER/IMPLANT TOOL

MEDTRONIC MODEL 5318 TEMPORARY PACEMAKER/IMPLANT TOOL is an FDA 510(k)-cleared medical device (K971474) manufactured by Medtronic Vascular. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on July 13, 1997. Regulation: 8.