Cleared Special

K190587 - Coolrail Linear Pen

K190587 is the FDA 510(k) clearance for Coolrail Linear Pen by AtriCure, Inc.. It is a Class 2 Cardiovascular device (product code OCL) cleared through the Special 510(k) pathway after a 139-day FDA review.

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

K190587 is an FDA 510(k) clearance for the Coolrail Linear Pen. Classified as Surgical Device, For Cutting, Coagulation, And/or Ablation Of Tissue, Including Cardiac Tissue (product code OCL), Class II - Special Controls.

Submitted by AtriCure, Inc. (Mason, US). The FDA issued a Cleared decision on July 24, 2019 after a review of 139 days - within the typical 510(k) review window.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 878.4400 - the FDA cardiovascular device oversight framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all AtriCure, Inc. devices

Submission Details

510(k) Number K190587 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
14d slower than avg
Panel avg: 125d · This submission: 139d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code OCL Surgical Device, For Cutting, Coagulation, And/or Ablation Of Tissue, Including Cardiac Tissue
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4400
Definition Surgical Device For Cutting, Coagulation, And/or Ablation Of Tissue, Including Cardiac Tissue
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Cardiovascular devices follow this clearance model.

Regulatory Peers - OCL Surgical Device, For Cutting, Coagulation, And/or Ablation Of Tissue, Including Cardiac Tissue

All 33
Devices cleared under the same product code (OCL) and FDA review panel - the closest regulatory comparables to K190587.
EPi-Sense Guided Coagulation System with VisiTrax
K193162 · AtriCure, Inc. · Dec 2019
Isolator Transpolar Pen, Isolator Long Pen TT, Isolator Linear Pen
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Cardioblate CryoFlex Surgical Ablation System
K191526 · Medtronic, Inc. · Oct 2019
Cardioblate Pen Surgical Ablation Device, Cardioblate XL Pen Surgical Ablation Device
K190623 · Medtronic · May 2019
COBRA Fusion Ablation System
K190151 · AtriCure, Inc. · Feb 2019
Valleylab FT10 Electrosurgical Platform, Cardioblate BP2 Surgical Ablation Device, Cardioblate LP Surgical Ablation Device
K182610 · Medtronic · Dec 2018