510(k) K970259

E-Z SET INFUSION SET/SAF-T E-Z SET INFUSION SET by Becton Dickinson Vascular Access, Inc. — Product Code FPA

K970259 is an FDA 510(k) premarket notification submitted by Becton Dickinson Vascular Access, Inc. for the device "E-Z SET INFUSION SET/SAF-T E-Z SET INFUSION SET". The FDA issued a decision of Substantially Equivalent on April 8, 1997. The device falls under product code FPA (Set, Administration, Intravascular), a Class II device regulated under 21 CFR 880.5440. Becton Dickinson Vascular Access, Inc. has at least 10 other 510(k) clearances on record.