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FDA 510(k)

CG+ 箭頭 JACC

K 號：K161765 · 2016-09-06

申請人Arrow International, Inc. (Subsidiary of Teleflex
決定日期2016-09-06
產品代碼LJS
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

CG+ Arrow JACC is the device name listed in this FDA 510(k) record. The listed applicant is Arrow International, Inc. (Subsidiary of Teleflex. It received FDA 510(k) clearance on 2016-09-06 under 510(k) number K161765. The device is classified under product code LJS. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the CG+ Arrow JACC?

CG+ Arrow JACC is a medical device that received FDA 510(k) clearance on 2016-09-06. The listed applicant is Arrow International, Inc. (Subsidiary of Teleflex. The 510(k) number is K161765.

When did CG+ Arrow JACC receive FDA 510(k) clearance?

CG+ Arrow JACC received FDA 510(k) clearance on 2016-09-06, under 510(k) number K161765.

Who is the listed applicant for CG+ Arrow JACC?

The FDA 510(k) record lists Arrow International, Inc. (Subsidiary of Teleflex as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CG+ Arrow JACC?

The FDA product code for CG+ Arrow JACC is LJS.

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相關器械（代碼：LJS）

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