510(k) K141722

CAREFUSION GOLD TISSUE MARKER by Care Fusion — Product Code NEU

K141722 is an FDA 510(k) premarket notification submitted by Care Fusion for the device "CAREFUSION GOLD TISSUE MARKER". The FDA issued a decision of Substantially Equivalent on January 23, 2015. The device falls under product code NEU (Marker, Radiographic, Implantable), a Class II device regulated under 21 CFR 878.4300. Care Fusion has at least 10 other 510(k) clearances on record.