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FDA 510(k)

20G x 1.25 NovaCath Secure IV Catheter System, 24G x 0.56 NovaCath Secure IV Catheter System

K 號：K160374 · 2016-03-11

申請人Tangent Medical Technologies, Inc.
決定日期2016-03-11
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

20G x 1.25 NovaCath Secure IV Catheter System, 24G x 0.56 NovaCath Secure IV Catheter System is the device name listed in this FDA 510(k) record. The listed applicant is Tangent Medical Technologies, Inc.. It received FDA 510(k) clearance on 2016-03-11 under 510(k) number K160374. 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 20G x 1.25 NovaCath Secure IV Catheter System, 24G x 0.56 NovaCath Secure IV Catheter System?

20G x 1.25 NovaCath Secure IV Catheter System, 24G x 0.56 NovaCath Secure IV Catheter System is a medical device that received FDA 510(k) clearance on 2016-03-11. The listed applicant is Tangent Medical Technologies, Inc.. The 510(k) number is K160374.

When did 20G x 1.25 NovaCath Secure IV Catheter System, 24G x 0.56 NovaCath Secure IV Catheter System receive FDA 510(k) clearance?

20G x 1.25 NovaCath Secure IV Catheter System, 24G x 0.56 NovaCath Secure IV Catheter System received FDA 510(k) clearance on 2016-03-11, under 510(k) number K160374.

Who is the listed applicant for 20G x 1.25 NovaCath Secure IV Catheter System, 24G x 0.56 NovaCath Secure IV Catheter System?

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

What is the FDA product code for 20G x 1.25 NovaCath Secure IV Catheter System, 24G x 0.56 NovaCath Secure IV Catheter System?

The FDA product code for 20G x 1.25 NovaCath Secure IV Catheter System, 24G x 0.56 NovaCath Secure IV Catheter System is FOZ.

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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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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