MODEL 1300 SOFTRACE II ELECTRODE

MODEL 1300 SOFTRACE II ELECTRODE is an FDA 510(k)-cleared medical device (K921164) 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 March 17, 1993. Regulation: 8.