Arisure Closed System Drug Transfer Device (CSTD)

Arisure Closed System Drug Transfer Device (CSTD) is an FDA 510(k)-cleared medical device (K201422) manufactured by Yukon Medical, LLC. 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 March 1, 2021. Regulation: 8.