FDA 510(k)

VERAFEYE System VERAFEYE Imaging Catheter & VERAFEYE Imaging System

N.º K: K242893 · 2025-03-24

Fecha de decisión2025-03-24

Código de productoOBJ

Comité asesorCV

DecisiónSubstantially Equivalent

Resumen del dispositivo

VERAFEYE System VERAFEYE Imaging Catheter & VERAFEYE Imaging System is the device name listed in this FDA 510(k) record. The listed applicant is Luma Vision Limited. It received FDA 510(k) clearance on 2025-03-24 under 510(k) number K242893. The device is classified under product code OBJ. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the VERAFEYE System VERAFEYE Imaging Catheter & VERAFEYE Imaging System?

VERAFEYE System VERAFEYE Imaging Catheter & VERAFEYE Imaging System is a medical device that received FDA 510(k) clearance on 2025-03-24. The listed applicant is Luma Vision Limited. The 510(k) number is K242893.

When did VERAFEYE System VERAFEYE Imaging Catheter & VERAFEYE Imaging System receive FDA 510(k) clearance?

VERAFEYE System VERAFEYE Imaging Catheter & VERAFEYE Imaging System received FDA 510(k) clearance on 2025-03-24, under 510(k) number K242893.

Who is the listed applicant for VERAFEYE System VERAFEYE Imaging Catheter & VERAFEYE Imaging System?

The FDA 510(k) record lists Luma Vision Limited as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for VERAFEYE System VERAFEYE Imaging Catheter & VERAFEYE Imaging System?

The FDA product code for VERAFEYE System VERAFEYE Imaging Catheter & VERAFEYE Imaging System is OBJ.

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Otros registros que enlistan a Luma Vision Limited como solicitante

K261849VERAFEYE Imaging Catheter (VF-VIC-002)K260885VERAFEYE Imaging and Guidance System (VF-VIS-002)

Dispositivos relacionados (Código: OBJ)

K261696ACUNAV Luxera 4D ICE CatheterSiemens Medical Solutions USA, Inc.K261849VERAFEYE Imaging Catheter (VF-VIC-002)Luma Vision Limited K252945Novasight Hybrid SystemConavi Medical, Inc.K260816OptiCross Coronary Imaging Catheter (H749518110); OptiCross 6 Coronary Imaging Catheter (H7495181160); OptiCross HD Coronary Imaging Catheter (H74939352040); OptiCross 6 HD Coronary Imaging Catheter (H74939354080); OptiCross Coronary Imaging Catheter (Bagless) (H749518130); OptiCross 6 Coronary Imaging Catheter (Bagless) (H7495181360); OptiCross HD Coronary Imaging Catheter (Bagless) (H74939352050); OptiCross 6 HD Coronary Imaging Catheter (Bagless) (H74939354090)Boston Scientific K253399Visions® PV .014P RX Digital IVUS Catheter ; Visions® PV .018 Digital IVUS CatheterVolcano Corporation (Dba Philips Image Guided Therapy Device K250955XC11 ICE System, USAYorlabs, Inc.

Fuente oficial

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