HYPERGLIDE OCCLUSION BALLOON SYSTEM, HYPERFORM OCCLUSION BALLOON SYSTEM, MODEL 104-4112, 104-4113, 104-4127,104-4132,104

HYPERGLIDE OCCLUSION BALLOON SYSTEM, HYPERFORM OCCLUSION BALLOON SYSTEM, MODEL 104-4112, 104-4113, 104-4127,104-4132,104 is an FDA 510(k)-cleared medical device (K091458) 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 October 14, 2009. Regulation: 8.