510(k) K060036

PORT-A-CATH, PORT-A-CATH II, PROPORT AND P.A.S. PORT IMPLANTABLE VENOUS ACCESS SYSTEMS WITH DUAL LAYER CATHETER by Smiths Medical MD, Inc. — Product Code LJT

K060036 is an FDA 510(k) premarket notification submitted by Smiths Medical MD, Inc. for the device "PORT-A-CATH, PORT-A-CATH II, PROPORT AND P.A.S. PORT IMPLANTABLE VENOUS ACCESS SYSTEMS WITH DUAL LAYER CATHETER". The FDA issued a decision of Substantially Equivalent on May 17, 2006. The device falls under product code LJT (Port & Catheter, Implanted, Subcutaneous, Intravascular), a Class II device regulated under 21 CFR 880.5965. Smiths Medical MD, Inc. has at least 10 other 510(k) clearances on record.