510(k) K070116

POWER PORT-A-CATH AND POWER PORT-A-CATH II; IMPLANTABLE VENOUS ACCESS SYSTEMS AND POWER GRIPPER PLUS NEEDLE by Smiths Medical MD, Inc. — Product Code LJT

K070116 is an FDA 510(k) premarket notification submitted by Smiths Medical MD, Inc. for the device "POWER PORT-A-CATH AND POWER PORT-A-CATH II; IMPLANTABLE VENOUS ACCESS SYSTEMS AND POWER GRIPPER PLUS NEEDLE". The FDA issued a decision of Substantially Equivalent on May 23, 2007. 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.