FDA 510(k)

BD Centro Vena 急性中心靜脈管 (7 法寸雙腔)

K 號：K200266 · 2020-04-07

申請人Bard Access Systems, Inc. (Bard Has Joined Bd)

決定日期2020-04-07

產品代碼FOZ

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

BD Centro Vena Acute Central Line (7 French Dual Lumen) is the device name listed in this FDA 510(k) record. The listed applicant is Bard Access Systems, Inc. (Bard Has Joined Bd). It received FDA 510(k) clearance on 2020-04-07 under 510(k) number K200266. The device is classified under product code FOZ. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the BD Centro Vena Acute Central Line (7 French Dual Lumen)?

BD Centro Vena Acute Central Line (7 French Dual Lumen) is a medical device that received FDA 510(k) clearance on 2020-04-07. The listed applicant is Bard Access Systems, Inc. (Bard Has Joined Bd). The 510(k) number is K200266.

When did BD Centro Vena Acute Central Line (7 French Dual Lumen) receive FDA 510(k) clearance?

BD Centro Vena Acute Central Line (7 French Dual Lumen) received FDA 510(k) clearance on 2020-04-07, under 510(k) number K200266.

Who is the listed applicant for BD Centro Vena Acute Central Line (7 French Dual Lumen)?

The FDA 510(k) record lists Bard Access Systems, Inc. (Bard Has Joined Bd) as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BD Centro Vena Acute Central Line (7 French Dual Lumen)?

The FDA product code for BD Centro Vena Acute Central Line (7 French Dual Lumen) is FOZ.

其他以 Bard Access Systems, Inc. (Bard Has Joined Bd) 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。

K190855BD 急性中心靜脈管

相關器械（代碼：FOZ）

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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