CATHETER BALLOON DILATOR PRESSURE GAUGE

CATHETER BALLOON DILATOR PRESSURE GAUGE is an FDA 510(k)-cleared medical device (K895511) manufactured by Argon Medical Corp.. 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 27, 1990. Regulation: 8.