EMBA Hourglass Peripheral Embolization Device (PED)

EMBA Hourglass Peripheral Embolization Device (PED) is an FDA 510(k)-cleared medical device (K200083) manufactured by Embolic Acceleration, 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 February 13, 2020. Regulation: 8.