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FDA 510(k)

EPi-Sense Guided Coagulation System with VisiTrax

K-Number: K193162 · 2019-12-13

ApplicantAtriCure, Inc.
Decision Date2019-12-13
Product CodeOCL
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

EPi-Sense Guided Coagulation System with VisiTrax is a medical device manufactured by AtriCure, Inc.. It received FDA 510(k) clearance on 2019-12-13 under approval 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. It is manufactured by AtriCure, Inc.. The 510(k) number is K193162.

When was EPi-Sense Guided Coagulation System with VisiTrax approved by the FDA?

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

What company makes EPi-Sense Guided Coagulation System with VisiTrax?

EPi-Sense Guided Coagulation System with VisiTrax is manufactured by AtriCure, Inc..

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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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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