EMBA Hourglass Peripheral Embolization Device

EMBA Hourglass Peripheral Embolization Device is an FDA 510(k)-cleared medical device (K171845) manufactured by Emba Medical Limited. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on August 17, 2017. Regulation: 8.