510(k) K181446

Bard Power-Injectable Implantable Ports (PowerPorts®) by C.R. Bard, Inc. — Product Code LJT

K181446 is an FDA 510(k) premarket notification submitted by C.R. Bard, Inc. for the device "Bard Power-Injectable Implantable Ports (PowerPorts®)". The FDA issued a decision of Substantially Equivalent on July 8, 2019. 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.