510(k) K121092

FLOWEASE [SUBCUTANEOUS] INFUSION SET by Baxter Healthcare Corp — Product Code FPA

K121092 is an FDA 510(k) premarket notification submitted by Baxter Healthcare Corp for the device "FLOWEASE [SUBCUTANEOUS] INFUSION SET". The FDA issued a decision of Substantially Equivalent on June 29, 2012. The device falls under product code FPA (Set, Administration, Intravascular), a Class II device regulated under 21 CFR 880.5440. Baxter Healthcare Corp has at least 10 other 510(k) clearances on record.