PRESSUREWIRE; CERTUS, CERTUS 300, AERIS, AERIS 300

PRESSUREWIRE; CERTUS, CERTUS 300, AERIS, AERIS 300 is an FDA 510(k)-cleared medical device (K131452) manufactured by St. Jude Medical Systems AB. 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 4, 2013. Regulation: 8.