FDA 510(k)

HydroMID 4F單腔中線導管

K 號：K220772 · 2022-12-07

決定日期2022-12-07

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

HydroMID 4F Single Lumen Midline Catheter is the device name listed in this FDA 510(k) record. The listed applicant is Access Vascular, Inc.. It received FDA 510(k) clearance on 2022-12-07 under 510(k) number K220772. 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 HydroMID 4F Single Lumen Midline Catheter?

HydroMID 4F Single Lumen Midline Catheter is a medical device that received FDA 510(k) clearance on 2022-12-07. The listed applicant is Access Vascular, Inc.. The 510(k) number is K220772.

When did HydroMID 4F Single Lumen Midline Catheter receive FDA 510(k) clearance?

HydroMID 4F Single Lumen Midline Catheter received FDA 510(k) clearance on 2022-12-07, under 510(k) number K220772.

Who is the listed applicant for HydroMID 4F Single Lumen Midline Catheter?

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

What is the FDA product code for HydroMID 4F Single Lumen Midline Catheter?

The FDA product code for HydroMID 4F Single Lumen Midline Catheter is FOZ.

其他以 Access Vascular, Inc. 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。

K243458HydroPICC 4Fr單腔標記針管，130 cm導絲 - 基本套件（70001301）；HydroPICC 4Fr單腔標記針管，70 cm導絲 - 基本套件（70001302）；HydroPICC 4Fr單腔標記針管 - 极限屏障套件（70001304）；HydroPICC 5Fr雙腔標記針管，130 cm導絲 - 基本套件（70002301）；HydroPICC 5Fr雙腔標記針管，70 cm導絲 - 基本套件（70002302）；HydroPICC 5Fr雙腔標記針管 - 极限屏障套件（70002304）；Hydr K251212雙腔道 5Fr HydroPICC 穿刺針 (PICC-251CM) (PICC-251CM)；雙腔道 5Fr HydroPICC 穿刺針 (PICC-252CM) (PICC-252CM)K244059HydroMID 5F雙腔中線導管 - 基本套件（70006102）；HydroMID 5F雙腔中線導管 - 最大防護套件（70006104）；HydroMID 5F雙腔中線導管 - 流動最大防護套件（90006104）K243941HydroPICC 4Fr單腔標記針管，130公分導絲 - 基本套件（70001201）；HydroPICC 4Fr單腔標記針管，70公分導絲 - 基本套件（70001202）；HydroPICC 4Fr單腔標記針管，極限屏障套件（70001204）；HydroPICC 4Fr單腔標記針管，移動極限屏障套件（90001204）K213550HydroPICC 5F雙腔導管 K203069水MID

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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。

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

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