FDA 510(k)

VIVANT BREAST LESION LOCALIZATION DEVICE

K-Number: K003439 · 2000-12-15

Decision Date2000-12-15

Product CodeKNW

Advisory CommitteeGU

DecisionSubstantially Equivalent

Device Summary

VIVANT BREAST LESION LOCALIZATION DEVICE is the device name listed in this FDA 510(k) record. The listed applicant is Vivant Medical, Inc.. It received FDA 510(k) clearance on 2000-12-15 under 510(k) number K003439. The device is classified under product code KNW. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VIVANT BREAST LESION LOCALIZATION DEVICE?

VIVANT BREAST LESION LOCALIZATION DEVICE is a medical device that received FDA 510(k) clearance on 2000-12-15. The listed applicant is Vivant Medical, Inc.. The 510(k) number is K003439.

When did VIVANT BREAST LESION LOCALIZATION DEVICE receive FDA 510(k) clearance?

VIVANT BREAST LESION LOCALIZATION DEVICE received FDA 510(k) clearance on 2000-12-15, under 510(k) number K003439.

Who is the listed applicant for VIVANT BREAST LESION LOCALIZATION DEVICE?

The FDA 510(k) record lists Vivant Medical, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for VIVANT BREAST LESION LOCALIZATION DEVICE?

The FDA product code for VIVANT BREAST LESION LOCALIZATION DEVICE is KNW.

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Related Devices (Code: KNW)

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Official Source

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