FDA 510(k)

化學CLAVE 溝毒藥物準備及輸送系統

K 號：K173477 · 2018-08-31

決定日期2018-08-31

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

ChemoCLAVE Cytotoxic Medication Preparation and Delivery System is the device name listed in this FDA 510(k) record. The listed applicant is Icu Medical, Inc.. It received FDA 510(k) clearance on 2018-08-31 under 510(k) number K173477. 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 ChemoCLAVE Cytotoxic Medication Preparation and Delivery System?

ChemoCLAVE Cytotoxic Medication Preparation and Delivery System is a medical device that received FDA 510(k) clearance on 2018-08-31. The listed applicant is Icu Medical, Inc.. The 510(k) number is K173477.

When did ChemoCLAVE Cytotoxic Medication Preparation and Delivery System receive FDA 510(k) clearance?

ChemoCLAVE Cytotoxic Medication Preparation and Delivery System received FDA 510(k) clearance on 2018-08-31, under 510(k) number K173477.

Who is the listed applicant for ChemoCLAVE Cytotoxic Medication Preparation and Delivery System?

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

What is the FDA product code for ChemoCLAVE Cytotoxic Medication Preparation and Delivery System?

The FDA product code for ChemoCLAVE Cytotoxic Medication Preparation and Delivery System is ONB.

其他以 Icu Medical, Inc. 為申請人之記錄

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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。

K251722ProSeal™ 轉移注射器（421120、421130、421140）Epic Medical Pte. , Ltd.K253033Chemfort® 28天 20mm 藥瓶適配器及 13mm 轉換器Simplivia Healthcare , Ltd.K250059BD PhaSeal™ Optima 連接組 (C83-O)；BD PhaSeal™ Optima 尖嘴組 (C180-O)Becton, Dickinson and Company K251411Chemfort 女性路氏釘釋針適配器Simplivia Healthcare , Ltd.K251340ProSeal™ 內袋釘針配附加孔 (423370ST, 423370)Epic Medical Pte. , Ltd.K243976ZeroClear™ 袋裝取用器（423100）Epic Medical Pte. , Ltd.

官方來源

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