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FDA 510(k)

Emprint Ablation Visualization Application

K-Number: K180192 · 2018-03-21

ApplicantCovidien, LLC
Decision Date2018-03-21
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Emprint Ablation Visualization Application is the device name listed in this FDA 510(k) record. The listed applicant is Covidien, LLC. It received FDA 510(k) clearance on 2018-03-21 under 510(k) number K180192. The device is classified under product code LLZ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Emprint Ablation Visualization Application?

Emprint Ablation Visualization Application is a medical device that received FDA 510(k) clearance on 2018-03-21. The listed applicant is Covidien, LLC. The 510(k) number is K180192.

When did Emprint Ablation Visualization Application receive FDA 510(k) clearance?

Emprint Ablation Visualization Application received FDA 510(k) clearance on 2018-03-21, under 510(k) number K180192.

Who is the listed applicant for Emprint Ablation Visualization Application?

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

What is the FDA product code for Emprint Ablation Visualization Application?

The FDA product code for Emprint Ablation Visualization Application is LLZ.

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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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