Bunegin-Albin Air Aspiration Set

Bunegin-Albin Air Aspiration Set is an FDA 510(k)-cleared medical device (K163031) manufactured by Cook Incorporated. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on July 26, 2017. Regulation: 8.