FDA 510(k)

High Pressure Tubing

Número K: K244038 · 2025-09-05

RequerenteShandong Int Medical Instruments Co., Ltd.

Data da decisão2025-09-05

Código do produtoDXT

Comité consultivoCV

DecisãoSubstantially Equivalent

Resumo do dispositivo

High Pressure Tubing is the device name listed in this FDA 510(k) record. The listed applicant is Shandong Int Medical Instruments Co., Ltd.. It received FDA 510(k) clearance on 2025-09-05 under 510(k) number K244038. The device is classified under product code DXT. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the High Pressure Tubing?

High Pressure Tubing is a medical device that received FDA 510(k) clearance on 2025-09-05. The listed applicant is Shandong Int Medical Instruments Co., Ltd.. The 510(k) number is K244038.

When did High Pressure Tubing receive FDA 510(k) clearance?

High Pressure Tubing received FDA 510(k) clearance on 2025-09-05, under 510(k) number K244038.

Who is the listed applicant for High Pressure Tubing?

The FDA 510(k) record lists Shandong Int Medical Instruments Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for High Pressure Tubing?

The FDA product code for High Pressure Tubing is DXT.

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Fonte oficial

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