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FDA 510(k)

TAV System

K-Number: K152664 · 2016-12-02

ApplicantNew Aera, Inc.
Decision Date2016-12-02
Product CodeONZ
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

TAV System is a medical device manufactured by New Aera, Inc.. It received FDA 510(k) clearance on 2016-12-02 under approval number K152664. The device is classified under product code ONZ. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TAV System?

TAV System is a medical device that received FDA 510(k) clearance on 2016-12-02. It is manufactured by New Aera, Inc.. The 510(k) number is K152664.

When was TAV System approved by the FDA?

TAV System received FDA 510(k) clearance on 2016-12-02, under approval number K152664.

What company makes TAV System?

TAV System is manufactured by New Aera, Inc..

What is the FDA product code for TAV System?

The FDA product code for TAV System is ONZ.

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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