510(k) K971293

LIFESHIELD PRIMARY I.V. SET WITH BACKCHECK VALVE by Abbott Mfg., Inc. — Product Code FPA

K971293 is an FDA 510(k) premarket notification submitted by Abbott Mfg., Inc. for the device "LIFESHIELD PRIMARY I.V. SET WITH BACKCHECK VALVE". The FDA issued a decision of Substantially Equivalent on June 27, 1997. The device falls under product code FPA (Set, Administration, Intravascular), a Class II device regulated under 21 CFR 880.5440. Abbott Mfg., Inc. has at least 10 other 510(k) clearances on record.