510(k) K033892

ULTRAFLEX INFUSION SET by Disetronic Medical Systems AG — Product Code FPA

K033892 is an FDA 510(k) premarket notification submitted by Disetronic Medical Systems AG for the device "ULTRAFLEX INFUSION SET". The FDA issued a decision of Substantially Equivalent on March 9, 2004. The device falls under product code FPA (Set, Administration, Intravascular), a Class II device regulated under 21 CFR 880.5440. Disetronic Medical Systems AG has at least 10 other 510(k) clearances on record.