510(k) K050310

BARDPORT TITANIUM PORTS by Bard Access Systems, Inc. — Product Code LJT

K050310 is an FDA 510(k) premarket notification submitted by Bard Access Systems, Inc. for the device "BARDPORT TITANIUM PORTS". The FDA issued a decision of Substantially Equivalent on April 18, 2005. The device falls under product code LJT (Port & Catheter, Implanted, Subcutaneous, Intravascular), a Class II device regulated under 21 CFR 880.5965. Bard Access Systems, Inc. has at least 10 other 510(k) clearances on record.