FDA 510(k)

Visualized Access and Delivery Catheter; PB Digital Controller

Номер K: K252492 · 2026-04-24

Дата решения2026-04-24

Код продуктаSHU

Консультативный комитетGU

РешениеSubstantially Equivalent

Описание устройства

Visualized Access and Delivery Catheter; PB Digital Controller 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 2026-04-24 under 510(k) number K252492. The device is classified under product code SHU. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Часто задаваемые вопросы

What is the Visualized Access and Delivery Catheter; PB Digital Controller?

Visualized Access and Delivery Catheter; PB Digital Controller is a medical device that received FDA 510(k) clearance on 2026-04-24. The listed applicant is Micro-Tech (Nanjing) Co., Ltd.. The 510(k) number is K252492.

When did Visualized Access and Delivery Catheter; PB Digital Controller receive FDA 510(k) clearance?

Visualized Access and Delivery Catheter; PB Digital Controller received FDA 510(k) clearance on 2026-04-24, under 510(k) number K252492.

Who is the listed applicant for Visualized Access and Delivery Catheter; PB Digital Controller?

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 Visualized Access and Delivery Catheter; PB Digital Controller?

The FDA product code for Visualized Access and Delivery Catheter; PB Digital Controller is SHU.

Связанные клинические исследования

Связанные записи сопоставляются автоматически на основании названий, кодов продукции или иных метаданных. Сопоставление не подтверждает клиническую, научную, корпоративную или регуляторную связь; ознакомьтесь с официальными источниками по ссылкам.

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