510(k) K120548

HLIC NEEDLE-LESS VALVE by Health Line International Corporation — Product Code FPA

K120548 is an FDA 510(k) premarket notification submitted by Health Line International Corporation for the device "HLIC NEEDLE-LESS VALVE". The FDA issued a decision of Substantially Equivalent on May 4, 2012. The device falls under product code FPA (Set, Administration, Intravascular), a Class II device regulated under 21 CFR 880.5440. Health Line International Corporation has at least 10 other 510(k) clearances on record.