510(k) K994111

CELSITE, MODELS ST401L, ST405L by B. Braun/Mcgaw — Product Code LJT

K994111 is an FDA 510(k) premarket notification submitted by B. Braun/Mcgaw for the device "CELSITE, MODELS ST401L, ST405L". The FDA issued a decision of Substantially Equivalent on January 3, 2000. The device falls under product code LJT (Port & Catheter, Implanted, Subcutaneous, Intravascular), a Class II device regulated under 21 CFR 880.5965. B. Braun/Mcgaw has at least 1 other 510(k) clearance on record.