PRESSURE TRIGGER MOD OF SMEC INTRA-AORT

PRESSURE TRIGGER MOD OF SMEC INTRA-AORT is an FDA 510(k)-cleared medical device (K840367) manufactured by Smec, 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 December 10, 1985. Regulation: 8.