EQUINOX OCCLUSION BALLOON SYSTEM

EQUINOX OCCLUSION BALLOON SYSTEM is an FDA 510(k)-cleared medical device (K990487) manufactured by Micro Therapeutics, 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 August 30, 1999. Regulation: 8.