510(k) K122834

POLYSITE IMPLANTABLE INFUSION PORTS by Perouse Medical — Product Code LJT

K122834 is an FDA 510(k) premarket notification submitted by Perouse Medical for the device "POLYSITE IMPLANTABLE INFUSION PORTS". The FDA issued a decision of Substantially Equivalent on December 11, 2013. The device falls under product code LJT (Port & Catheter, Implanted, Subcutaneous, Intravascular), a Class II device regulated under 21 CFR 880.5965. Perouse Medical has at least 2 other 510(k) clearances on record.