PRESSURE GAUGE ACCESSORY KIT/DILATATION

PRESSURE GAUGE ACCESSORY KIT/DILATATION is an FDA 510(k)-cleared medical device (K802261) manufactured by Stanco Medical, 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 October 2, 1980. Regulation: 8.