HEARTPORT ENDOPULMONARY VENT CATHETER

HEARTPORT ENDOPULMONARY VENT CATHETER is an FDA 510(k)-cleared medical device (K981009) 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 September 3, 1998. Regulation: 8.