510(k) K241976

nextaro® va, 15mm, 5µm by Sfm Medical Devices GmbH — Product Code LHI

K241976 is an FDA 510(k) premarket notification submitted by Sfm Medical Devices GmbH for the device "nextaro® va, 15mm, 5µm". The FDA issued a decision of Substantially Equivalent on September 6, 2024. The device falls under product code LHI (Set, I.V. Fluid Transfer), a Class II device regulated under 21 CFR 880.5440. Sfm Medical Devices GmbH has at least 2 other 510(k) clearances on record.