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FDA 510(k)

Thoraguard System

K-Number: K181667 · 2018-11-29

ApplicantCentese, Inc.
Decision Date2018-11-29
Product CodeBTA
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Thoraguard System is a medical device manufactured by Centese, Inc.. It received FDA 510(k) clearance on 2018-11-29 under approval number K181667. 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 Thoraguard System?

Thoraguard System is a medical device that received FDA 510(k) clearance on 2018-11-29. It is manufactured by Centese, Inc.. The 510(k) number is K181667.

When was Thoraguard System approved by the FDA?

Thoraguard System received FDA 510(k) clearance on 2018-11-29, under approval number K181667.

What company makes Thoraguard System?

Thoraguard System is manufactured by Centese, Inc..

What is the FDA product code for Thoraguard System?

The FDA product code for Thoraguard System is BTA.

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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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