510(k) K151969

Hospira Extension Sets by Icu Medical, Inc. — Product Code FPA

K151969 is an FDA 510(k) premarket notification submitted by Icu Medical, Inc. for the device "Hospira Extension Sets". The FDA issued a decision of Substantially Equivalent on January 19, 2016. The device falls under product code FPA (Set, Administration, Intravascular), a Class II device regulated under 21 CFR 880.5440. Icu Medical, Inc. has at least 10 other 510(k) clearances on record.