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FDA 510(k)

Cornaris Intravascular Imaging System (P80-E); Cornaris Intravascular Imaging System (Mobile-E); LumenCross Imaging Catheter (F2)

N.º K: K242098 · 2025-04-11

SolicitanteShenzhen Vivolight Medical Device & Technology Co., Ltd.
Fecha de decisión2025-04-11
Código de productoNQQ
Comité asesorRA
DecisiónSubstantially Equivalent

Resumen del dispositivo

Cornaris Intravascular Imaging System (P80-E); Cornaris Intravascular Imaging System (Mobile-E); LumenCross Imaging Catheter (F2) is the device name listed in this FDA 510(k) record. The listed applicant is Shenzhen Vivolight Medical Device & Technology Co., Ltd.. It received FDA 510(k) clearance on 2025-04-11 under 510(k) number K242098. The device is classified under product code NQQ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the Cornaris Intravascular Imaging System (P80-E); Cornaris Intravascular Imaging System (Mobile-E); LumenCross Imaging Catheter (F2)?

Cornaris Intravascular Imaging System (P80-E); Cornaris Intravascular Imaging System (Mobile-E); LumenCross Imaging Catheter (F2) is a medical device that received FDA 510(k) clearance on 2025-04-11. The listed applicant is Shenzhen Vivolight Medical Device & Technology Co., Ltd.. The 510(k) number is K242098.

When did Cornaris Intravascular Imaging System (P80-E); Cornaris Intravascular Imaging System (Mobile-E); LumenCross Imaging Catheter (F2) receive FDA 510(k) clearance?

Cornaris Intravascular Imaging System (P80-E); Cornaris Intravascular Imaging System (Mobile-E); LumenCross Imaging Catheter (F2) received FDA 510(k) clearance on 2025-04-11, under 510(k) number K242098.

Who is the listed applicant for Cornaris Intravascular Imaging System (P80-E); Cornaris Intravascular Imaging System (Mobile-E); LumenCross Imaging Catheter (F2)?

The FDA 510(k) record lists Shenzhen Vivolight Medical Device & Technology Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Cornaris Intravascular Imaging System (P80-E); Cornaris Intravascular Imaging System (Mobile-E); LumenCross Imaging Catheter (F2)?

The FDA product code for Cornaris Intravascular Imaging System (P80-E); Cornaris Intravascular Imaging System (Mobile-E); LumenCross Imaging Catheter (F2) is NQQ.

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Dispositivos relacionados (Código: NQQ)

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

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