FDA 510(k)

Jab de Aspiración de Ultrasonido Endobronquial AreusTM, Jab de Aspiración de Ultrasonido Endobronquial TridentTM

N.º K: K213060 · 2022-07-20

SolicitanteMicro-Tech (Nanjing) Co., Ltd.

Fecha de decisión2022-07-20

Código de productoKTI

Comité asesorEN

DecisiónSubstantially Equivalent

Resumen del dispositivo

AreusTM Endobronchial Ultrasound Aspiration Needle, TridentTM Endobronchial Ultrasound Aspiration Needle is the device name listed in this FDA 510(k) record. The listed applicant is Micro-Tech (Nanjing) Co., Ltd.. It received FDA 510(k) clearance on 2022-07-20 under 510(k) number K213060. The device is classified under product code KTI. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the AreusTM Endobronchial Ultrasound Aspiration Needle, TridentTM Endobronchial Ultrasound Aspiration Needle?

AreusTM Endobronchial Ultrasound Aspiration Needle, TridentTM Endobronchial Ultrasound Aspiration Needle is a medical device that received FDA 510(k) clearance on 2022-07-20. The listed applicant is Micro-Tech (Nanjing) Co., Ltd.. The 510(k) number is K213060.

When did AreusTM Endobronchial Ultrasound Aspiration Needle, TridentTM Endobronchial Ultrasound Aspiration Needle receive FDA 510(k) clearance?

AreusTM Endobronchial Ultrasound Aspiration Needle, TridentTM Endobronchial Ultrasound Aspiration Needle received FDA 510(k) clearance on 2022-07-20, under 510(k) number K213060.

Who is the listed applicant for AreusTM Endobronchial Ultrasound Aspiration Needle, TridentTM Endobronchial Ultrasound Aspiration Needle?

The FDA 510(k) record lists Micro-Tech (Nanjing) Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for AreusTM Endobronchial Ultrasound Aspiration Needle, TridentTM Endobronchial Ultrasound Aspiration Needle?

The FDA product code for AreusTM Endobronchial Ultrasound Aspiration Needle, TridentTM Endobronchial Ultrasound Aspiration Needle is KTI.

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Otros registros que enlistan a Micro-Tech (Nanjing) Co., Ltd. como solicitante

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Dispositivos relacionados (Código: KTI)

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Fuente oficial

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