HEARTPORT ENDOPULMONARY VENT

HEARTPORT ENDOPULMONARY VENT is an FDA 510(k)-cleared medical device (K961245) manufactured by Heartport, Inc.. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on June 17, 1996. Regulation: 8.