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FDA 510(k)

Arisure 關閉系統藥物輸送設備 (CSTD)

K 號：K201422 · 2021-03-02

申請人Yukon Medical, LLC
決定日期2021-03-02
產品代碼ONB
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

Arisure Closed System Drug Transfer Device (CSTD) is the device name listed in this FDA 510(k) record. The listed applicant is Yukon Medical, LLC. It received FDA 510(k) clearance on 2021-03-02 under 510(k) number K201422. The device is classified under product code ONB. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Arisure Closed System Drug Transfer Device (CSTD)?

Arisure Closed System Drug Transfer Device (CSTD) is a medical device that received FDA 510(k) clearance on 2021-03-02. The listed applicant is Yukon Medical, LLC. The 510(k) number is K201422.

When did Arisure Closed System Drug Transfer Device (CSTD) receive FDA 510(k) clearance?

Arisure Closed System Drug Transfer Device (CSTD) received FDA 510(k) clearance on 2021-03-02, under 510(k) number K201422.

Who is the listed applicant for Arisure Closed System Drug Transfer Device (CSTD)?

The FDA 510(k) record lists Yukon Medical, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Arisure Closed System Drug Transfer Device (CSTD)?

The FDA product code for Arisure Closed System Drug Transfer Device (CSTD) is ONB.

相關臨床試驗

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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其他以 Yukon Medical, LLC 為申請人之記錄

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。

K240761Arisure® 關閉男性路爾與針適配器 (YM060)K243486SmartSite™ 通氣安瓿瓶進入設備

相關器械（代碼：ONB）

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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