510(k) K120872

ASANTE CONSET AND ASANTE COMFORT SUBCUTANEOUS INFUSION SETS FOR USE WITH ASANTE PEARL INFUSION PUMPS by Unomedical A/S Infusion Devices — Product Code FPA

K120872 is an FDA 510(k) premarket notification submitted by Unomedical A/S Infusion Devices for the device "ASANTE CONSET AND ASANTE COMFORT SUBCUTANEOUS INFUSION SETS FOR USE WITH ASANTE PEARL INFUSION PUMPS". The FDA issued a decision of Substantially Equivalent on Apr 20, 2012. The device falls under product code FPA (Set, Administration, Intravascular), a Class II device regulated under 21 CFR 880.5440.