510(k) K130576

CELSITE IMPLANTABLE ACCESS PORT SYSTEMS by B. Braun Interventional Systems, Inc. — Product Code LJT

K130576 is an FDA 510(k) premarket notification submitted by B. Braun Interventional Systems, Inc. for the device "CELSITE IMPLANTABLE ACCESS PORT SYSTEMS". The FDA issued a decision of Substantially Equivalent on April 2, 2013. The device falls under product code LJT (Port & Catheter, Implanted, Subcutaneous, Intravascular), a Class II device regulated under 21 CFR 880.5965. B. Braun Interventional Systems, Inc. has at least 2 other 510(k) clearances on record.