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FDA 510(k)

AtriCure Isolator Encompass Ablation System, GLIDEPATH Magnetic GUIDE

K-Number: K210477 · 2021-07-26

ApplicantAtriCure, Inc.
Decision Date2021-07-26
Product CodeOCL
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

AtriCure Isolator Encompass Ablation System, GLIDEPATH Magnetic GUIDE is a medical device manufactured by AtriCure, Inc.. It received FDA 510(k) clearance on 2021-07-26 under approval number K210477. 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 AtriCure Isolator Encompass Ablation System, GLIDEPATH Magnetic GUIDE?

AtriCure Isolator Encompass Ablation System, GLIDEPATH Magnetic GUIDE is a medical device that received FDA 510(k) clearance on 2021-07-26. It is manufactured by AtriCure, Inc.. The 510(k) number is K210477.

When was AtriCure Isolator Encompass Ablation System, GLIDEPATH Magnetic GUIDE approved by the FDA?

AtriCure Isolator Encompass Ablation System, GLIDEPATH Magnetic GUIDE received FDA 510(k) clearance on 2021-07-26, under approval number K210477.

What company makes AtriCure Isolator Encompass Ablation System, GLIDEPATH Magnetic GUIDE?

AtriCure Isolator Encompass Ablation System, GLIDEPATH Magnetic GUIDE is manufactured by AtriCure, Inc..

What is the FDA product code for AtriCure Isolator Encompass Ablation System, GLIDEPATH Magnetic GUIDE?

The FDA product code for AtriCure Isolator Encompass Ablation System, GLIDEPATH Magnetic GUIDE 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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