510(k) K922147

DUAL PLASTIC VASCULAR ACCESS SYSTEM by Gerard Medical Enterprises, Inc. — Product Code LJT

K922147 is an FDA 510(k) premarket notification submitted by Gerard Medical Enterprises, Inc. for the device "DUAL PLASTIC VASCULAR ACCESS SYSTEM". The FDA issued a decision of Substantially Equivalent on December 4, 1992. 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.