510(k) K890518

SINGLE LUMEN S.E.A.-PORT VASCULAR ACCESS SYSTEM by Harbor Medical Devices, Inc. — Product Code LJT

K890518 is an FDA 510(k) premarket notification submitted by Harbor Medical Devices, Inc. for the device "SINGLE LUMEN S.E.A.-PORT VASCULAR ACCESS SYSTEM". The FDA issued a decision of Substantially Equivalent on April 21, 1989. The device falls under product code LJT (Port & Catheter, Implanted, Subcutaneous, Intravascular), a Class II device regulated under 21 CFR 880.5965. Harbor Medical Devices, Inc. has at least 6 other 510(k) clearances on record.