EleVation Breast Biopsy Driver, EleVation Breast Biopsy Probe - 10G, EleVation Breast Biopsy Probe - 14G

Instrument, Biopsy

Bard Peripheral Vascular, Inc.

The following data is part of a premarket notification filed by Bard Peripheral Vascular, Inc. with the FDA for Elevation Breast Biopsy Driver, Elevation Breast Biopsy Probe - 10g, Elevation Breast Biopsy Probe - 14g.

Pre-market Notification Details

Device IDK192948
501k NumberK192948
Device Name:EleVation Breast Biopsy Driver, EleVation Breast Biopsy Probe - 10G, EleVation Breast Biopsy Probe - 14G
ClassificationInstrument, Biopsy
Applicant Bard Peripheral Vascular, Inc. 1625 West 3rd Street Tempe,  AZ  85281
ContactMeghan Mckelvey
CorrespondentMeghan Mckelvey
Bard Peripheral Vascular, Inc. 1625 West 3rd Street Tempe,  AZ  85281
Product CodeKNW  
CFR Regulation Number876.1075 [🔎]
DecisionSubstantially Equivalent (SESE)
Regulation Medical SpecialtyGastroenterology/Urology
501k Review PanelGeneral & Plastic Surgery
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-10-18
Decision Date2019-11-07

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