BD PhaSeal Optima Closed System Drug Transfer Device

BD PhaSeal Optima Closed System Drug Transfer Device is an FDA 510(k)-cleared medical device (K201099) manufactured by Becton, Dickinson and Company. This device is classified under the General Hospital specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on August 11, 2020. Regulation: 8.