510(k) K140492

NEXSITE HD (55CM), HEMODIALYSIS CATHETER FOR LONG TERM USE by Marvao Medical Devices, Ltd. — Product Code MSD

K140492 is an FDA 510(k) premarket notification submitted by Marvao Medical Devices, Ltd. for the device "NEXSITE HD (55CM), HEMODIALYSIS CATHETER FOR LONG TERM USE". The FDA issued a decision of Substantially Equivalent on November 13, 2014. The device falls under product code MSD (Catheter, Hemodialysis, Implanted), a Class II device regulated under 21 CFR 876.5540. Marvao Medical Devices, Ltd. has at least 8 other 510(k) clearances on record.