510(k) K242660

Curlin 8000 Ambulatory Infusion System; Enterprise Solution (ES) Software; Curlin 380-series Administration Sets by Zevex, Inc. — Product Code FRN

K242660 is an FDA 510(k) premarket notification submitted by Zevex, Inc. for the device "Curlin 8000 Ambulatory Infusion System; Enterprise Solution (ES) Software; Curlin 380-series Administration Sets". The FDA issued a decision of Substantially Equivalent on October 3, 2024. The device falls under product code FRN (Pump, Infusion), a Class II device regulated under 21 CFR 880.5725. Zevex, Inc. has at least 4 other 510(k) clearances on record.