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FDA 510(k)

TLAB® Transvenous Liver Biopsy System (TF-18C)

N.º K: K241145 · 2024-08-01

SolicitanteArgon Medical Devices, Inc.
Fecha de decisión2024-08-01
Código de productoDYB
Comité asesorCV
DecisiónSubstantially Equivalent

Resumen del dispositivo

TLAB® Transvenous Liver Biopsy System (TF-18C) is the device name listed in this FDA 510(k) record. The listed applicant is Argon Medical Devices, Inc.. It received FDA 510(k) clearance on 2024-08-01 under 510(k) number K241145. The device is classified under product code DYB. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the TLAB® Transvenous Liver Biopsy System (TF-18C)?

TLAB® Transvenous Liver Biopsy System (TF-18C) is a medical device that received FDA 510(k) clearance on 2024-08-01. The listed applicant is Argon Medical Devices, Inc.. The 510(k) number is K241145.

When did TLAB® Transvenous Liver Biopsy System (TF-18C) receive FDA 510(k) clearance?

TLAB® Transvenous Liver Biopsy System (TF-18C) received FDA 510(k) clearance on 2024-08-01, under 510(k) number K241145.

Who is the listed applicant for TLAB® Transvenous Liver Biopsy System (TF-18C)?

The FDA 510(k) record lists Argon Medical Devices, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for TLAB® Transvenous Liver Biopsy System (TF-18C)?

The FDA product code for TLAB® Transvenous Liver Biopsy System (TF-18C) is DYB.

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Otros registros que enlistan a Argon Medical Devices, Inc. como solicitante

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Dispositivos relacionados (Código: DYB)

Los registros relacionados se emparejan automáticamente mediante nombres, códigos de producto u otros metadatos. Un emparejamiento no establece una relación clínica, científica, corporativa o regulatoria verificada; revise las fuentes oficiales enlazadas.

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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.

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