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FDA 510(k)

TACVAC

K-Number: K153459 · 2016-01-28

ApplicantAthena Gtx
Decision Date2016-01-28
Product CodeBTA
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

TACVAC is the device name listed in this FDA 510(k) record. The listed applicant is Athena Gtx. It received FDA 510(k) clearance on 2016-01-28 under 510(k) number K153459. The device is classified under product code BTA. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TACVAC?

TACVAC is a medical device that received FDA 510(k) clearance on 2016-01-28. The listed applicant is Athena Gtx. The 510(k) number is K153459.

When did TACVAC receive FDA 510(k) clearance?

TACVAC received FDA 510(k) clearance on 2016-01-28, under 510(k) number K153459.

Who is the listed applicant for TACVAC?

The FDA 510(k) record lists Athena Gtx as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for TACVAC?

The FDA product code for TACVAC is BTA.

Other records listing Athena Gtx as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

Related Devices (Code: BTA)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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.