MODIFICATION TO HYPERGLIDE OCCLUSION BALLOON SYSTEM

MODIFICATION TO HYPERGLIDE OCCLUSION BALLOON SYSTEM is an FDA 510(k)-cleared medical device (K021066) 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 June 17, 2002. Regulation: 8.