510(k) K102890

K-SHIELD SMALL VEIN INFUSION / WINGED COLLECTION SET W/ ANTI NEEDLE STICK PROTECTOR (AND MULTISAMPLE LUER ADAPTER) by Kawasumi Laboratories America, Inc. — Product Code FPA

K102890 is an FDA 510(k) premarket notification submitted by Kawasumi Laboratories America, Inc. for the device "K-SHIELD SMALL VEIN INFUSION / WINGED COLLECTION SET W/ ANTI NEEDLE STICK PROTECTOR (AND MULTISAMPLE LUER ADAPTER)". The FDA issued a decision of Substantially Equivalent on October 21, 2010. The device falls under product code FPA (Set, Administration, Intravascular), a Class II device regulated under 21 CFR 880.5440. Kawasumi Laboratories America, Inc. has at least 5 other 510(k) clearances on record.