COAXIAL BIPOLAR PACING ELECTRODE

COAXIAL BIPOLAR PACING ELECTRODE is an FDA 510(k)-cleared medical device (K822239) manufactured by Burditt & Calkins-Siemens-Elema. This device is classified under the Cardiovascular specialty. FDA Device Class III (Premarket Approval) — highest risk category. FDA clearance granted on October 3, 1982. Regulation: 8.