FDA 510(k)

EPi-Sense Guided Coagulation System with VisiTrax

K-Number: K193162 · 2019-12-13

Decision Date2019-12-13

Product CodeOCL

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

EPi-Sense Guided Coagulation System with VisiTrax is the device name listed in this FDA 510(k) record. The listed applicant is AtriCure, Inc.. It received FDA 510(k) clearance on 2019-12-13 under 510(k) number K193162. The device is classified under product code OCL. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EPi-Sense Guided Coagulation System with VisiTrax?

EPi-Sense Guided Coagulation System with VisiTrax is a medical device that received FDA 510(k) clearance on 2019-12-13. The listed applicant is AtriCure, Inc.. The 510(k) number is K193162.

When did EPi-Sense Guided Coagulation System with VisiTrax receive FDA 510(k) clearance?

EPi-Sense Guided Coagulation System with VisiTrax received FDA 510(k) clearance on 2019-12-13, under 510(k) number K193162.

Who is the listed applicant for EPi-Sense Guided Coagulation System with VisiTrax?

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

What is the FDA product code for EPi-Sense Guided Coagulation System with VisiTrax?

The FDA product code for EPi-Sense Guided Coagulation System with VisiTrax is OCL.

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Related Devices (Code: OCL)

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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.