Cleared Special

Coolrail Linear Pen

K183065 · AtriCure, Inc. · Cardiovascular
Dec 2018
Decision
29d
Days
Class 2
Risk

About This 510(k) Submission

K183065 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 December 4, 2018, 29 days after receiving the submission on November 5, 2018. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 878.4400.

Submission Details

510(k) Number K183065 FDA.gov
FDA Decision Cleared SESE
Date Received November 05, 2018
Decision Date December 04, 2018
Days to Decision 29 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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