510(k) K153228

NMI Port, NMI Port II by Navilyst Medical, Inc. — Product Code LJT

K153228 is an FDA 510(k) premarket notification submitted by Navilyst Medical, Inc. for the device "NMI Port, NMI Port II". The FDA issued a decision of Substantially Equivalent on December 4, 2015. The device falls under product code LJT (Port & Catheter, Implanted, Subcutaneous, Intravascular), a Class II device regulated under 21 CFR 880.5965. Navilyst Medical, Inc. has at least 10 other 510(k) clearances on record.