510(k) K140169

VITAL-PORT(R) CT VASCULAR ACCESS SYSTEM by Cook Incorporated — Product Code LJT

K140169 is an FDA 510(k) premarket notification submitted by Cook Incorporated for the device "VITAL-PORT(R) CT VASCULAR ACCESS SYSTEM". The FDA issued a decision of Substantially Equivalent on May 21, 2014. The device falls under product code LJT (Port & Catheter, Implanted, Subcutaneous, Intravascular), a Class II device regulated under 21 CFR 880.5965. Cook Incorporated has at least 10 other 510(k) clearances on record.