510(k) K180061

UltraCor Twirl Breast Tissue Marker by Bard Peripheral Vascular, Inc. — Product Code NEU

K180061 is an FDA 510(k) premarket notification submitted by Bard Peripheral Vascular, Inc. for the device "UltraCor Twirl Breast Tissue Marker". The FDA issued a decision of Substantially Equivalent on March 9, 2018. The device falls under product code NEU (Marker, Radiographic, Implantable), a Class II device regulated under 21 CFR 878.4300. Bard Peripheral Vascular, Inc. has at least 10 other 510(k) clearances on record.