510(k) K211933

EleVation Breast Biopsy System by Bard Peripheral Vascular — Product Code KNW

K211933 is an FDA 510(k) premarket notification submitted by Bard Peripheral Vascular for the device "EleVation Breast Biopsy System". The FDA issued a decision of Substantially Equivalent on July 15, 2021. The device falls under product code KNW (Instrument, Biopsy), a Class II device regulated under 21 CFR 876.1075. Bard Peripheral Vascular has at least 10 other 510(k) clearances on record.