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FDA 510(k)

UltraCor Twirl Breast Tissue Marker

K-Number: K180061 · 2018-03-09

ApplicantBard Peripheral Vascular, Inc.
Decision Date2018-03-09
Product CodeNEU
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

UltraCor Twirl Breast Tissue Marker is a medical device manufactured by Bard Peripheral Vascular, Inc.. It received FDA 510(k) clearance on 2018-03-09 under approval number K180061. The device is classified under product code NEU. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the UltraCor Twirl Breast Tissue Marker?

UltraCor Twirl Breast Tissue Marker is a medical device that received FDA 510(k) clearance on 2018-03-09. It is manufactured by Bard Peripheral Vascular, Inc.. The 510(k) number is K180061.

When was UltraCor Twirl Breast Tissue Marker approved by the FDA?

UltraCor Twirl Breast Tissue Marker received FDA 510(k) clearance on 2018-03-09, under approval number K180061.

What company makes UltraCor Twirl Breast Tissue Marker?

UltraCor Twirl Breast Tissue Marker is manufactured by Bard Peripheral Vascular, Inc..

What is the FDA product code for UltraCor Twirl Breast Tissue Marker?

The FDA product code for UltraCor Twirl Breast Tissue Marker is NEU.

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Other Devices by Bard Peripheral Vascular, Inc.

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Related Devices (Code: NEU)

K152510UltraCor Twirl Breast Tissue MarkerBard Peripheral Vascular, Inc. K161021HydroMARK Breast Biopsy Site MarkerDevicor Medical Products, Inc. K171767Cianna Medical SAVI Scout Reflector and SAVI Scout SystemCianna Medical, Inc. K170803HydroMARK Breast Biopsy Site MarkersDevicor Medical Products, Inc. K170026Radiopaque Tissue MarkerViscus Biologics, LLC K170905Star Tissue MarkerScion Medical Technologies, LLC

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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