HYPERGLIDE AND HYPERFORM OCCLUSION BALLOON SYSTEMS

HYPERGLIDE AND HYPERFORM OCCLUSION BALLOON SYSTEMS is an FDA 510(k)-cleared medical device (K101570) manufactured by Micro Therapeutics Dba Ev3 Neurovascular. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on July 12, 2010. Regulation: 8.