FDA 510(k)

Isolator Synergy EnCapture Ablation System (EMH)

N.º K: K234151 · 2024-08-27

Fecha de decisión2024-08-27

Código de productoOCL

Comité asesorSU

DecisiónSubstantially Equivalent

Resumen del dispositivo

Isolator Synergy EnCapture Ablation System (EMH) is the device name listed in this FDA 510(k) record. The listed applicant is AtriCure, Inc.. It received FDA 510(k) clearance on 2024-08-27 under 510(k) number K234151. The device is classified under product code OCL. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the Isolator Synergy EnCapture Ablation System (EMH)?

Isolator Synergy EnCapture Ablation System (EMH) is a medical device that received FDA 510(k) clearance on 2024-08-27. The listed applicant is AtriCure, Inc.. The 510(k) number is K234151.

When did Isolator Synergy EnCapture Ablation System (EMH) receive FDA 510(k) clearance?

Isolator Synergy EnCapture Ablation System (EMH) received FDA 510(k) clearance on 2024-08-27, under 510(k) number K234151.

Who is the listed applicant for Isolator Synergy EnCapture Ablation System (EMH)?

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 Isolator Synergy EnCapture Ablation System (EMH)?

The FDA product code for Isolator Synergy EnCapture Ablation System (EMH) is OCL.

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Otros registros que enlistan a AtriCure, Inc. como solicitante

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)K234125AtriClip FLEX-Mini LAA Exclusion System (ACHM)K233959EPi-Ease Epicardial Access Device (EAS)

Ver todos los 32 dispositivos →

Dispositivos relacionados (Código: OCL)

K252056Isolator® Synergy™ EnCompass Clamp and Guide system (OLH, OSH, GPM100)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.K211311AtriCure Isolator® Synergy™ Surgical Ablation SystemAtriCure, Inc.K200514Cardioblate Gemini-s Surgical Ablation DeviceMedtronic

Fuente oficial

Ver en la base de datos de la FDA →

Datos procedentes de la API abierta de la FDA. Para obtener la información más actualizada y autoritativa, consulte siempre el registro oficial.