FDA 510(k)

VERAFEYE Imaging Catheter (VF-VIC-002)

N.º K: K261849 · 2026-07-24

Fecha de decisión2026-07-24

Código de productoOBJ

Comité asesorCV

DecisiónSubstantially Equivalent

Resumen del dispositivo

VERAFEYE Imaging Catheter (VF-VIC-002) 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 2026-07-24 under 510(k) number K261849. 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 Imaging Catheter (VF-VIC-002)?

VERAFEYE Imaging Catheter (VF-VIC-002) is a medical device that received FDA 510(k) clearance on 2026-07-24. The listed applicant is Luma Vision Limited. The 510(k) number is K261849.

When did VERAFEYE Imaging Catheter (VF-VIC-002) receive FDA 510(k) clearance?

VERAFEYE Imaging Catheter (VF-VIC-002) received FDA 510(k) clearance on 2026-07-24, under 510(k) number K261849.

Who is the listed applicant for VERAFEYE Imaging Catheter (VF-VIC-002)?

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 Imaging Catheter (VF-VIC-002)?

The FDA product code for VERAFEYE Imaging Catheter (VF-VIC-002) is OBJ.

Ensayos clínicos relacionados

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Otros registros que enlistan a Luma Vision Limited como solicitante

K260885VERAFEYE Imaging and Guidance System (VF-VIS-002)K242893VERAFEYE System VERAFEYE Imaging Catheter & VERAFEYE Imaging System

Dispositivos relacionados (Código: OBJ)

K261696ACUNAV Luxera 4D ICE CatheterSiemens Medical Solutions USA, Inc.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.K250913TINGSN FINDERS 2 Color Doppler Diagnostic Ultrasound SystemJiangsu Tingsn Technology Co., Ltd.

Fuente oficial

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