UltraCor Twirl Breast Tissue Marker

Marker, Radiographic, Implantable

Bard Peripheral Vascular, Inc.

The following data is part of a premarket notification filed by Bard Peripheral Vascular, Inc. with the FDA for Ultracor Twirl Breast Tissue Marker.

Pre-market Notification Details

Device IDK180061
510k NumberK180061
Device Name:UltraCor Twirl Breast Tissue Marker
ClassificationMarker, Radiographic, Implantable
Applicant Bard Peripheral Vascular, Inc. 1625 W. 3rd Street Tempe,  AZ  85281
ContactMeghan Mckelvey
CorrespondentMeghan Mckelvey
Bard Peripheral Vascular, Inc. 1625 W. 3rd Street Tempe,  AZ  85281
Product CodeNEU  
CFR Regulation Number878.4300 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2018-01-08
Decision Date2018-03-09
Summary:summary

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