510(k) K161036

Hospira Extension Set, Hospira Primary Set by Hospira, Inc. — Product Code FPA

K161036 is an FDA 510(k) premarket notification submitted by Hospira, Inc. for the device "Hospira Extension Set, Hospira Primary Set". The FDA issued a decision of Substantially Equivalent on January 6, 2017. The device falls under product code FPA (Set, Administration, Intravascular), a Class II device regulated under 21 CFR 880.5440. Hospira, Inc. has at least 10 other 510(k) clearances on record.