510(k) K860952

I.V. SET WITH AND WITHOUT AIR VENT by Migada, Ltd. — Product Code FPA

K860952 is an FDA 510(k) premarket notification submitted by Migada, Ltd. for the device "I.V. SET WITH AND WITHOUT AIR VENT". The FDA issued a decision of Substantially Equivalent on August 27, 1986. The device falls under product code FPA (Set, Administration, Intravascular), a Class II device regulated under 21 CFR 880.5440. Migada, Ltd. has at least 10 other 510(k) clearances on record.