510(k) K921201

VITAL-PORT M.R.I. DUAL LUMEN VASCULAR ACCESS SYST. by Med Institute, Inc. — Product Code LJT

K921201 is an FDA 510(k) premarket notification submitted by Med Institute, Inc. for the device "VITAL-PORT M.R.I. DUAL LUMEN VASCULAR ACCESS SYST.". The FDA issued a decision of Substantially Equivalent on July 21, 1992. The device falls under product code LJT (Port & Catheter, Implanted, Subcutaneous, Intravascular), a Class II device regulated under 21 CFR 880.5965. Med Institute, Inc. has at least 10 other 510(k) clearances on record.