ALTERNATE SIZE E-Z-PACE ELECTRODE

ALTERNATE SIZE E-Z-PACE ELECTRODE is an FDA 510(k)-cleared medical device (K862298) 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 10, 1986. Regulation: 8.