510(k) K150514

Power-Injectable Implantable Ports with ChronoFlex Polyurethane Catheters by C.R. Bard, Inc. — Product Code LJT

K150514 is an FDA 510(k) premarket notification submitted by C.R. Bard, Inc. for the device "Power-Injectable Implantable Ports with ChronoFlex Polyurethane Catheters". The FDA issued a decision of Substantially Equivalent on November 20, 2015. The device falls under product code LJT (Port & Catheter, Implanted, Subcutaneous, Intravascular), a Class II device regulated under 21 CFR 880.5965. C.R. Bard, Inc. has at least 10 other 510(k) clearances on record.