510(k) K951922

ADMINISTRATION SETS WITH BALL FLOAT by Imed Corp. — Product Code FPA

K951922 is an FDA 510(k) premarket notification submitted by Imed Corp. for the device "ADMINISTRATION SETS WITH BALL FLOAT". The FDA issued a decision of Substantially Equivalent on July 19, 1995. The device falls under product code FPA (Set, Administration, Intravascular), a Class II device regulated under 21 CFR 880.5440. Imed Corp. has at least 10 other 510(k) clearances on record.