SARNS MEDIASTINAL AND PERICARDIAL TUBE

SARNS MEDIASTINAL AND PERICARDIAL TUBE is an FDA 510(k)-cleared medical device (K792070) manufactured by 3M Health Care, Sarns. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on November 20, 1979. Regulation: 8.