510(k) K903364

GERARD MEDICAL, INC. TRIM-PORT by Gerard Medical Enterprises, Inc. — Product Code LJT

K903364 is an FDA 510(k) premarket notification submitted by Gerard Medical Enterprises, Inc. for the device "GERARD MEDICAL, INC. TRIM-PORT". The FDA issued a decision of Substantially Equivalent (kit) on October 31, 1990. The device falls under product code LJT (Port & Catheter, Implanted, Subcutaneous, Intravascular), a Class II device regulated under 21 CFR 880.5965. Gerard Medical Enterprises, Inc. has at least 7 other 510(k) clearances on record.