510(k) K081425

COOK VASCULAR INC. VITAL-PORT VASCULAR ACCESS SYSTEM POWER INJECTABLE PORT by Cook Vascular, Inc. — Product Code LJT

K081425 is an FDA 510(k) premarket notification submitted by Cook Vascular, Inc. for the device "COOK VASCULAR INC. VITAL-PORT VASCULAR ACCESS SYSTEM POWER INJECTABLE PORT". The FDA issued a decision of Substantially Equivalent on September 30, 2008. The device falls under product code LJT (Port & Catheter, Implanted, Subcutaneous, Intravascular), a Class II device regulated under 21 CFR 880.5965. Cook Vascular, Inc. has at least 10 other 510(k) clearances on record.