AUGEASE VASCULAR AUGMENTATION DEVICE

AUGEASE VASCULAR AUGMENTATION DEVICE is an FDA 510(k)-cleared medical device (K101355) manufactured by Augdvt, LLC. 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 25, 2010. Regulation: 8.