510(k) K100946

INTRAVSCULAR ADMINISTRATION SET by Terumo Europe N.V. — Product Code FPA

K100946 is an FDA 510(k) premarket notification submitted by Terumo Europe N.V. for the device "INTRAVSCULAR ADMINISTRATION SET". The FDA issued a decision of Substantially Equivalent on August 2, 2010. The device falls under product code FPA (Set, Administration, Intravascular), a Class II device regulated under 21 CFR 880.5440. Terumo Europe N.V. has at least 10 other 510(k) clearances on record.