510(k) K192948

EleVation Breast Biopsy Driver, EleVation Breast Biopsy Probe - 10G, EleVation Breast Biopsy Probe - 14G by Bard Peripheral Vascular, Inc. — Product Code KNW

K192948 is an FDA 510(k) premarket notification submitted by Bard Peripheral Vascular, Inc. for the device "EleVation Breast Biopsy Driver, EleVation Breast Biopsy Probe - 10G, EleVation Breast Biopsy Probe - 14G". The FDA issued a decision of Substantially Equivalent on November 7, 2019. The device falls under product code KNW (Instrument, Biopsy), a Class II device regulated under 21 CFR 876.1075. Bard Peripheral Vascular, Inc. has at least 10 other 510(k) clearances on record.