FDA 510(k)

AtriCure Isolator® Synergy™ Surgical Ablation System

Número K: K211311 · 2021-05-28

Data da decisão2021-05-28

Código do produtoOCL

Comité consultivoSU

DecisãoSubstantially Equivalent

Resumo do dispositivo

AtriCure Isolator® Synergy™ Surgical Ablation System is the device name listed in this FDA 510(k) record. The listed applicant is AtriCure, Inc.. It received FDA 510(k) clearance on 2021-05-28 under 510(k) number K211311. 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® Synergy™ Surgical Ablation System?

AtriCure Isolator® Synergy™ Surgical Ablation System is a medical device that received FDA 510(k) clearance on 2021-05-28. The listed applicant is AtriCure, Inc.. The 510(k) number is K211311.

When did AtriCure Isolator® Synergy™ Surgical Ablation System receive FDA 510(k) clearance?

AtriCure Isolator® Synergy™ Surgical Ablation System received FDA 510(k) clearance on 2021-05-28, under 510(k) number K211311.

Who is the listed applicant for AtriCure Isolator® Synergy™ Surgical Ablation System?

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® Synergy™ Surgical Ablation System?

The FDA product code for AtriCure Isolator® Synergy™ Surgical Ablation System is OCL.

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Outros registros que listam AtriCure, Inc. como candidato(a)

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)K234151Isolator Synergy EnCapture Ablation System (EMH)K234125AtriClip FLEX-Mini LAA Exclusion System (ACHM)

Ver todos os 32 dispositivos →

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.K210477AtriCure Isolator Encompass Ablation System, GLIDEPATH Magnetic GUIDEAtriCure, Inc.K200514Cardioblate Gemini-s Surgical Ablation DeviceMedtronic

Fonte oficial

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