510(k) K110627

NEXSITE 9FR DUAL LUMEN CRITICAL CARE CENTRAL VENOUS CATHETER by Marvao Medical Devices, Ltd. — Product Code LJS

K110627 is an FDA 510(k) premarket notification submitted by Marvao Medical Devices, Ltd. for the device "NEXSITE 9FR DUAL LUMEN CRITICAL CARE CENTRAL VENOUS CATHETER". The FDA issued a decision of Substantially Equivalent on August 12, 2011. The device falls under product code LJS (Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days), a Class II device regulated under 21 CFR 880.5970. Marvao Medical Devices, Ltd. has at least 8 other 510(k) clearances on record.