510(k) K121032

PRIMARY SYMBIQ SET, DITAL MICROBORE TUBING, 0.2 MICRON FILTER, NON-DEHP by Hospira, Inc. — Product Code FPA

K121032 is an FDA 510(k) premarket notification submitted by Hospira, Inc. for the device "PRIMARY SYMBIQ SET, DITAL MICROBORE TUBING, 0.2 MICRON FILTER, NON-DEHP". The FDA issued a decision of Substantially Equivalent on June 21, 2012. 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.