FDA 510(k)

K-SHIELD Advantage PORT ACCESS 灌注設備高壓管路

K 號：K252355 · 2025-11-26

決定日期2025-11-26

產品代碼PTI

諮詢委員會醫療設備規範文本翻譯如下： HO 注意：原文中未提供具體的醫療設備規範文本，因此上述翻譯僅為示例。請提供完整的規範文本以便進行準確翻譯。

決定相當於

器材摘要

K-SHIELD Advantage PORT ACCESS INFUSION SET With High Pressure Tubing is the device name listed in this FDA 510(k) record. The listed applicant is Sb-Kawasumi Laboratories, Inc.. It received FDA 510(k) clearance on 2025-11-26 under 510(k) number K252355. The device is classified under product code PTI. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the K-SHIELD Advantage PORT ACCESS INFUSION SET With High Pressure Tubing?

K-SHIELD Advantage PORT ACCESS INFUSION SET With High Pressure Tubing is a medical device that received FDA 510(k) clearance on 2025-11-26. The listed applicant is Sb-Kawasumi Laboratories, Inc.. The 510(k) number is K252355.

When did K-SHIELD Advantage PORT ACCESS INFUSION SET With High Pressure Tubing receive FDA 510(k) clearance?

K-SHIELD Advantage PORT ACCESS INFUSION SET With High Pressure Tubing received FDA 510(k) clearance on 2025-11-26, under 510(k) number K252355.

Who is the listed applicant for K-SHIELD Advantage PORT ACCESS INFUSION SET With High Pressure Tubing?

The FDA 510(k) record lists Sb-Kawasumi Laboratories, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for K-SHIELD Advantage PORT ACCESS INFUSION SET With High Pressure Tubing?

The FDA product code for K-SHIELD Advantage PORT ACCESS INFUSION SET With High Pressure Tubing is PTI.

其他以 Sb-Kawasumi Laboratories, Inc. 為申請人之記錄

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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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官方來源

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