FDA 510(k)

AtriCure Isolator Encompass Ablation System, GLIDEPATH Magnetic GUIDE

K-Number: K210477 · 2021-07-26

Decision Date2021-07-26

Product CodeOCL

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

AtriCure Isolator Encompass Ablation System, GLIDEPATH Magnetic GUIDE is the device name listed in this FDA 510(k) record. The listed applicant is AtriCure, Inc.. It received FDA 510(k) clearance on 2021-07-26 under 510(k) 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. The listed applicant is AtriCure, Inc.. The 510(k) number is K210477.

When did AtriCure Isolator Encompass Ablation System, GLIDEPATH Magnetic GUIDE receive FDA 510(k) clearance?

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

Who is the listed applicant for AtriCure Isolator Encompass Ablation System, GLIDEPATH Magnetic GUIDE?

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 AtriCure Isolator Encompass Ablation System, GLIDEPATH Magnetic GUIDE?

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

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT05111015Tracking Results of Ablations to Combat AF Registry Generation 2RECRUITING NCT06989775BoxX-NoAF Clinical TrialRECRUITING NCT05107635Inappropriate Sinus Tachycardia RegistryRECRUITING NCT05110989A Multicenter Patient Registry on Outcomes From Cryoanalgesia of the Intercostal NervesRECRUITING NCT06908538Cryo NerVe Block Extremity AmputatioN RegIStry for Post Operative and pHantom Limb PainRECRUITING

Other records listing AtriCure, Inc. as applicant

PMA P200002Surgical cardiac ablation device, for treatment of atrial fibrillation PMA P100046Surgical cardiac ablation device, for treatment of atrial fibrillation K252056Isolator® Synergy™ EnCompass Clamp and Guide system (OLH, OSH, GPM100)K250371cryoICE cryoXT cryoablation probe (cryoXT)K243860AtriClip PRO-Mini LAA Exclusion System (PROM)K243157AtriCure cryoICE BOX (ACM)

View all 34 devices →

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.K211311AtriCure Isolator® Synergy™ Surgical Ablation SystemAtriCure, Inc.K200514Cardioblate Gemini-s Surgical Ablation DeviceMedtronic

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.