510(k) K951814

TRIUMPH-1 PORT by Horizon Medical Products, Inc. — Product Code LJT

K951814 is an FDA 510(k) premarket notification submitted by Horizon Medical Products, Inc. for the device "TRIUMPH-1 PORT". The FDA issued a decision of Substantially Equivalent on Aug 29, 1995. The device falls under product code LJT (Port & Catheter, Implanted, Subcutaneous, Intravascular), a Class II device regulated under 21 CFR 880.5965. Horizon Medical Products, Inc. has 15 other 510(k) clearances on record.