FDA 510(k)

高壓管路

K 號：K244038 · 2025-09-05

申請人Shandong Int Medical Instruments Co., Ltd.

決定日期2025-09-05

產品代碼DXT

諮詢委員會履歷

決定相當於

器材摘要

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.

常見問題

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.

其他以 Shandong Int Medical Instruments Co., Ltd. 為申請人之記錄

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K242143血管造影注射器

相關器械（代碼：DXT）

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

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