MODEL F UNIPOLAR ENDOCARDIAL LEAD-

MODEL F UNIPOLAR ENDOCARDIAL LEAD- is an FDA 510(k)-cleared medical device (K832255) manufactured by Cook Pacemaker Corp.. This device is classified under the Cardiovascular specialty. FDA Device Class III (Premarket Approval) — highest risk category. FDA clearance granted on August 11, 1983. Regulation: 8.