HYPERGLIDE OCCLUSION BALLOON SYSTEM, MODEL 104-4310, 104-4315

HYPERGLIDE OCCLUSION BALLOON SYSTEM, MODEL 104-4310, 104-4315 is an FDA 510(k)-cleared medical device (K092495) manufactured by 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 September 21, 2009. Regulation: 8.