MEDTRONIC OVERPRESSURE/VACUUM RELIEF VALVE

MEDTRONIC OVERPRESSURE/VACUUM RELIEF VALVE is an FDA 510(k)-cleared medical device (K953564) manufactured by Medtronic Cardiac Surgery, Medtronic, 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 February 1, 1996. Regulation: 8.