510(k) K974533

TRIMPORT by Gerard Medical, Inc. — Product Code LJT

K974533 is an FDA 510(k) premarket notification submitted by Gerard Medical, Inc. for the device "TRIMPORT". The FDA issued a decision of Substantially Equivalent on May 7, 1998. The device falls under product code LJT (Port & Catheter, Implanted, Subcutaneous, Intravascular), a Class II device regulated under 21 CFR 880.5965. Gerard Medical, Inc. has at least 3 other 510(k) clearances on record.