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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 the device name listed in this FDA 510(k) record. The listed applicant is Centese, Inc.. It received FDA 510(k) clearance on 2018-11-29 under 510(k) 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. The listed applicant is Centese, Inc.. The 510(k) number is K181667.

When did Thoraguard System receive FDA 510(k) clearance?

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

Who is the listed applicant for Thoraguard System?

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

What is the FDA product code for Thoraguard System?

The FDA product code for Thoraguard System is BTA.

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.

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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.

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