510(k) K031266

SURSHIELD SAFETY WINGED INFUSION SET by Terumo Corp. — Product Code FPA

K031266 is an FDA 510(k) premarket notification submitted by Terumo Corp. for the device "SURSHIELD SAFETY WINGED INFUSION SET". The FDA issued a decision of Substantially Equivalent on May 30, 2003. The device falls under product code FPA (Set, Administration, Intravascular), a Class II device regulated under 21 CFR 880.5440. Terumo Corp. has at least 10 other 510(k) clearances on record.