FDA 510(k)

領先式迷你型及領先式奈米型

K 號：K212370 · 2022-08-29

決定日期2022-08-29

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

Leaderflex Mini and Leaderflex Nano is the device name listed in this FDA 510(k) record. The listed applicant is Vygon USA. It received FDA 510(k) clearance on 2022-08-29 under 510(k) number K212370. 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 Leaderflex Mini and Leaderflex Nano?

Leaderflex Mini and Leaderflex Nano is a medical device that received FDA 510(k) clearance on 2022-08-29. The listed applicant is Vygon USA. The 510(k) number is K212370.

When did Leaderflex Mini and Leaderflex Nano receive FDA 510(k) clearance?

Leaderflex Mini and Leaderflex Nano received FDA 510(k) clearance on 2022-08-29, under 510(k) number K212370.

Who is the listed applicant for Leaderflex Mini and Leaderflex Nano?

The FDA 510(k) record lists Vygon USA as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Leaderflex Mini and Leaderflex Nano?

The FDA product code for Leaderflex Mini and Leaderflex Nano is FOZ.

其他以 Vygon USA 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。

K243361Nutrifit K181208維瓊中線3F SL 腹腔鏈條導管；維瓊中線4F SL 腹腔鏈條導管；維瓊中線5F DL 腹腔鏈條導管 K172899維瓊 PICCs

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。

K260432Ruby 靜脈內導管Venocare, Inc.K260165未浸潤中心靜脈針管Spectrum Vascular K261041ClearSafe 關閉系統MedSource Labs, LLC K260539MedSource QuickSafe™ 安全靜脈針管；MedSource PurSafe™ 安全靜脈針管MedSource Labs, LLC K253235Introcan Safety® 深層進入XL IV 腔管B.Braun Medical, Inc.K252137BD Insyte® I.V. 穿刺針Becton Dickinson Infusion Therapy Systems, Inc.

官方來源

在 FDA 資料庫中查看 →

資料來源為 FDA Open API。如需最新且權威的資訊，請始終參閱官方記錄。