Cleared Special

Coolrail Linear Pen

K190587 · AtriCure, Inc. · Cardiovascular
Jul 2019
Decision
139d
Days
Class 2
Risk

About This 510(k) Submission

K190587 is an FDA 510(k) clearance for the Coolrail Linear Pen, 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 July 24, 2019, 139 days after receiving the submission on March 7, 2019. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 878.4400.

Submission Details

510(k) Number K190587 FDA.gov
FDA Decision Cleared SESE
Date Received March 07, 2019
Decision Date July 24, 2019
Days to Decision 139 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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