PuraCath Firefly Needleless Connector IT (9005)

PuraCath Firefly Needleless Connector IT (9005) is an FDA 510(k)-cleared medical device (K251375) manufactured by Puracath Medical, Inc.. 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 February 11, 2026. Regulation: 8.