SIRECUST 425, RESPECTIVELY SIRECUST 430

SIRECUST 425, RESPECTIVELY SIRECUST 430 is an FDA 510(k)-cleared medical device (K851637) manufactured by Siemens Medical Solutions USA, 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 11, 1985. Regulation: 8.