EDSLAB (R) OCCLUSION BALLOON CATHETER

EDSLAB (R) OCCLUSION BALLOON CATHETER is an FDA 510(k)-cleared medical device (K873485) manufactured by American Edwards Laboratories. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on December 2, 1987. Regulation: 8.