510(k) K120281

DIGNITY POWER INJECTABLE TITANIUM PORT by Medical Components, Inc. — Product Code LJT

K120281 is an FDA 510(k) premarket notification submitted by Medical Components, Inc. for the device "DIGNITY POWER INJECTABLE TITANIUM PORT". The FDA issued a decision of Substantially Equivalent on September 17, 2012. The device falls under product code LJT (Port & Catheter, Implanted, Subcutaneous, Intravascular), a Class II device regulated under 21 CFR 880.5965. Medical Components, Inc. has at least 10 other 510(k) clearances on record.