Cleared Special

EPi-Sense Guided Coagulation System with VisiTrax

K193162 · AtriCure, Inc. · Cardiovascular

Dec 2019

Decision

28d

Days

Class 2

Risk

About This 510(k) Submission

K193162 is an FDA 510(k) clearance for the EPi-Sense Guided Coagulation System with VisiTrax, a Surgical Device, For Cutting, Coagulation, And/or Ablation Of Tissue, Including Cardiac Tissue (Class II — Special Controls, product code OCL), submitted by AtriCure, Inc. (West Chester, US). The FDA issued a Cleared decision on December 13, 2019, 28 days after receiving the submission on November 15, 2019. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 878.4400.

Submission Details

510(k) Number	K193162 FDA.gov
FDA Decision	Cleared SESE
Date Received	November 15, 2019
Decision Date	December 13, 2019
Days to Decision	28 days
Submission Type	Special
Review Panel	Cardiovascular (CV)
Summary	Summary PDF

Device Classification

Product Code	OCL — Surgical Device, For Cutting, Coagulation, And/or Ablation Of Tissue, Including Cardiac Tissue
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 878.4400
Definition	Surgical Device For Cutting, Coagulation, And/or Ablation Of Tissue, Including Cardiac Tissue