510(k) K992880

P.A.S. PORT ELITE IMPLANTABLE VENOUS ACCESS SYSTEM by Sims Deltec, Inc. — Product Code LJT

K992880 is an FDA 510(k) premarket notification submitted by Sims Deltec, Inc. for the device "P.A.S. PORT ELITE IMPLANTABLE VENOUS ACCESS SYSTEM". The FDA issued a decision of Substantially Equivalent on October 19, 1999. The device falls under product code LJT (Port & Catheter, Implanted, Subcutaneous, Intravascular), a Class II device regulated under 21 CFR 880.5965. Sims Deltec, Inc. has at least 10 other 510(k) clearances on record.