510(k) K052475

VYGON NUTRILINE AND NUTRILINE TWINFLOW CATHETERS by Vygon Us, LLC — Product Code LJS

K052475 is an FDA 510(k) premarket notification submitted by Vygon Us, LLC for the device "VYGON NUTRILINE AND NUTRILINE TWINFLOW CATHETERS". The FDA issued a decision of Substantially Equivalent on Sep 14, 2006. 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. Vygon Us, LLC has 2 other 510(k) clearances on record.