FDA 510(k)

Coolrail Linear Pen

K-Number: K183065 · 2018-12-04

Decision Date2018-12-04

Product CodeOCL

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

Coolrail Linear Pen is the device name listed in this FDA 510(k) record. The listed applicant is AtriCure, Inc.. It received FDA 510(k) clearance on 2018-12-04 under 510(k) number K183065. The device is classified under product code OCL. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Coolrail Linear Pen?

Coolrail Linear Pen is a medical device that received FDA 510(k) clearance on 2018-12-04. The listed applicant is AtriCure, Inc.. The 510(k) number is K183065.

When did Coolrail Linear Pen receive FDA 510(k) clearance?

Coolrail Linear Pen received FDA 510(k) clearance on 2018-12-04, under 510(k) number K183065.

Who is the listed applicant for Coolrail Linear Pen?

The FDA 510(k) record lists AtriCure, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Coolrail Linear Pen?

The FDA product code for Coolrail Linear Pen is OCL.

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Other records listing AtriCure, Inc. as applicant

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Related Devices (Code: OCL)

K252056Isolator® Synergy™ EnCompass Clamp and Guide system (OLH, OSH, GPM100)AtriCure, Inc.K234151Isolator Synergy EnCapture Ablation System (EMH)AtriCure, Inc.K221358Isolator® Linear Pen (MLP1); Isolator® Transpolar™ Pen (MAX1, MAX5), Coolrail® Linear Pen (MCR1); Isolator® Synergy Surgical Ablation System (EMR2, EML2); Isolator® Synergy™ EnCompass Clamp (OLH, OSH) and Guide System; Isolator® Synergy Access Clamp (EMT1)AtriCure, Inc.K223508Cardioblate Gemini-s 49260 Surgical Ablation Device; Cardioblate Gemini-s 49351 Surgical Ablation DeviceMedtronic, Inc.K210477AtriCure Isolator Encompass Ablation System, GLIDEPATH Magnetic GUIDEAtriCure, Inc.K211311AtriCure Isolator® Synergy™ Surgical Ablation SystemAtriCure, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.