HEARTPORT DIRECT AORTIC RETURN CANNULA WITH INTRODUCER

HEARTPORT DIRECT AORTIC RETURN CANNULA WITH INTRODUCER is an FDA 510(k)-cleared medical device (K974736) 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 July 14, 1998. Regulation: 8.