510(k) K945551

CELSITE(TM) DUAL VENOUS SYSTEM by B. Braun of America, Inc. — Product Code LJT

K945551 is an FDA 510(k) premarket notification submitted by B. Braun of America, Inc. for the device "CELSITE(TM) DUAL VENOUS SYSTEM". The FDA issued a decision of Substantially Equivalent on April 21, 1995. The device falls under product code LJT (Port & Catheter, Implanted, Subcutaneous, Intravascular), a Class II device regulated under 21 CFR 880.5965. B. Braun of America, Inc. has at least 10 other 510(k) clearances on record.