TEMPORARY ENDOCARDIAL TRIPOLAR LD. #6880

TEMPORARY ENDOCARDIAL TRIPOLAR LD. #6880 is an FDA 510(k)-cleared medical device (K811318) 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 19, 1981. Regulation: 8.