510(k) K070189

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

K070189 is an FDA 510(k) premarket notification submitted by Disetronic Medical Systems AG for the device "ACCU-CHEK ULTRAFLEX INFUSION SET". The FDA issued a decision of Substantially Equivalent on February 21, 2007. 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.