FDA 510(k)

AtriCure Isolator Encompass Ablation System, GLIDEPATH Magnetic GUIDE

Número K: K210477 · 2021-07-26

Data da decisão2021-07-26

Código do produtoOCL

Comité consultivoSU

DecisãoSubstantially Equivalent

Resumo do dispositivo

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.

Perguntas frequentes

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.

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Dispositivos Relacionados (Código: 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

Fonte oficial

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