510(k) K081515

NEOMED DUAL LUMEN UMBILICAL CATHETER, MODELS S2UVC4.0, S2UVC5.0 by Neomed, Inc. — Product Code FOS

K081515 is an FDA 510(k) premarket notification submitted by Neomed, Inc. for the device "NEOMED DUAL LUMEN UMBILICAL CATHETER, MODELS S2UVC4.0, S2UVC5.0". The FDA issued a decision of Substantially Equivalent on July 21, 2008. The device falls under product code FOS (Catheter, Umbilical Artery), a Class II device regulated under 21 CFR 880.5200. Neomed, Inc. has at least 10 other 510(k) clearances on record.