FDA 510(k)

BardPort®、SlimPort® 及 X-Port® 埋入式港道

K 號：K153359 · 2016-05-20

決定日期2016-05-20

產品代碼LJT

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

BardPort®, SlimPort®, and X-Port® Implanted Ports is the device name listed in this FDA 510(k) record. The listed applicant is C.R. Bard, Inc.. It received FDA 510(k) clearance on 2016-05-20 under 510(k) number K153359. The device is classified under product code LJT. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the BardPort®, SlimPort®, and X-Port® Implanted Ports?

BardPort®, SlimPort®, and X-Port® Implanted Ports is a medical device that received FDA 510(k) clearance on 2016-05-20. The listed applicant is C.R. Bard, Inc.. The 510(k) number is K153359.

When did BardPort®, SlimPort®, and X-Port® Implanted Ports receive FDA 510(k) clearance?

BardPort®, SlimPort®, and X-Port® Implanted Ports received FDA 510(k) clearance on 2016-05-20, under 510(k) number K153359.

Who is the listed applicant for BardPort®, SlimPort®, and X-Port® Implanted Ports?

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

What is the FDA product code for BardPort®, SlimPort®, and X-Port® Implanted Ports?

The FDA product code for BardPort®, SlimPort®, and X-Port® Implanted Ports is LJT.

其他以 C.R. Bard, Inc. 為申請人之記錄

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相關器械（代碼：LJT）

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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