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FDA 510(k)

Coolrail Linear Pen

K-Number: K190587 · 2019-07-24

ApplicantAtriCure, Inc.
Decision Date2019-07-24
Product CodeOCL
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Coolrail Linear Pen is a medical device manufactured by AtriCure, Inc.. It received FDA 510(k) clearance on 2019-07-24 under approval number K190587. 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 2019-07-24. It is manufactured by AtriCure, Inc.. The 510(k) number is K190587.

When was Coolrail Linear Pen approved by the FDA?

Coolrail Linear Pen received FDA 510(k) clearance on 2019-07-24, under approval number K190587.

What company makes Coolrail Linear Pen?

Coolrail Linear Pen is manufactured by AtriCure, Inc..

What is the FDA product code for Coolrail Linear Pen?

The FDA product code for Coolrail Linear Pen is OCL.

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Related Devices (Code: OCL)

K163408Isolator Multifunctional Linear PenAtriCure, Inc. K182610Valleylab FT10 Electrosurgical Platform, Cardioblate BP2 Surgical Ablation Device, Cardioblate LP Surgical Ablation DeviceMedtronic K183065Coolrail Linear PenAtriCure, Inc. K193162EPi-Sense Guided Coagulation System with VisiTraxAtriCure, Inc. K192125Isolator Transpolar Pen, Isolator Long Pen TT, Isolator Linear PenAtriCure, Inc. K191526Cardioblate CryoFlex Surgical Ablation SystemMedtronic, 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.

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