FLOWEASE [SUBCUTANEOUS] INFUSION SET

FLOWEASE [SUBCUTANEOUS] INFUSION SET is an FDA 510(k)-cleared medical device (K121092) manufactured by Baxter Healthcare Corp. 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 June 28, 2012. Regulation: 8.