CIRQLATOR INTRATHORACIC PRESSURE REGULATOR (ITPR)

CIRQLATOR INTRATHORACIC PRESSURE REGULATOR (ITPR) is an FDA 510(k)-cleared medical device (K070490) manufactured by Advanced Circulatory Systems, Inc.. This device is classified under the Anesthesiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on June 19, 2007. Regulation: 8.