IMPLANTABLE ENDOCARDIAL SCREW-IN ELEC

IMPLANTABLE ENDOCARDIAL SCREW-IN ELEC is an FDA 510(k)-cleared medical device (K791732) manufactured by Oscor, Inc.. This device is classified under the Cardiovascular specialty. FDA Device Class III (Premarket Approval) — highest risk category. FDA clearance granted on September 18, 1979. Regulation: 8.