510(k) K133867

SURFLO WINGED INFUSION SET WITH NEEDLE PROTECTION (SURSHIELD) by Terumo Europe N.V. — Product Code FPA

K133867 is an FDA 510(k) premarket notification submitted by Terumo Europe N.V. for the device "SURFLO WINGED INFUSION SET WITH NEEDLE PROTECTION (SURSHIELD)". The FDA issued a decision of Substantially Equivalent on February 5, 2014. 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.