EleVation Breast Biopsy System

Instrument, Biopsy

Bard Peripheral Vascular

The following data is part of a premarket notification filed by Bard Peripheral Vascular with the FDA for Elevation Breast Biopsy System.

Pre-market Notification Details

Device IDK211933
510k NumberK211933
Device Name:EleVation Breast Biopsy System
ClassificationInstrument, Biopsy
Applicant Bard Peripheral Vascular 1625 W. 3rd Street Tempe,  AZ  85281
ContactMeghan Mckelvey
CorrespondentMeghan Mckelvey
Bard Peripheral Vascular 1625 W. 3rd Street Tempe,  AZ  85281
Product CodeKNW  
CFR Regulation Number876.1075 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-06-22
Decision Date2021-07-15

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