Cleared Special

COBRA Fusion Ablation System

K190151 · AtriCure, Inc. · Cardiovascular
Feb 2019
Decision
26d
Days
Class 2
Risk

About This 510(k) Submission

K190151 is an FDA 510(k) clearance for the COBRA Fusion Ablation System, 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 February 25, 2019, 26 days after receiving the submission on January 30, 2019. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 878.4400.

Submission Details

510(k) Number K190151 FDA.gov
FDA Decision Cleared SESE
Date Received January 30, 2019
Decision Date February 25, 2019
Days to Decision 26 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

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