FDA 510(k)

雙腔道 5Fr HydroPICC 穿刺針 (PICC-251CM) (PICC-251CM)；雙腔道 5Fr HydroPICC 穿刺針 (PICC-252CM) (PICC-252CM)

K 號：K251212 · 2025-07-01

決定日期2025-07-01

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

Dual Lumen 5Fr HydroPICC Catheter (PICC-251CM) (PICC-251CM); Dual Lumen 5Fr HydroPICC Catheter (PICC-252CM) (PICC-252CM) 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 2025-07-01 under 510(k) number K251212. 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 Dual Lumen 5Fr HydroPICC Catheter (PICC-251CM) (PICC-251CM); Dual Lumen 5Fr HydroPICC Catheter (PICC-252CM) (PICC-252CM)?

Dual Lumen 5Fr HydroPICC Catheter (PICC-251CM) (PICC-251CM); Dual Lumen 5Fr HydroPICC Catheter (PICC-252CM) (PICC-252CM) is a medical device that received FDA 510(k) clearance on 2025-07-01. The listed applicant is Access Vascular, Inc.. The 510(k) number is K251212.

When did Dual Lumen 5Fr HydroPICC Catheter (PICC-251CM) (PICC-251CM); Dual Lumen 5Fr HydroPICC Catheter (PICC-252CM) (PICC-252CM) receive FDA 510(k) clearance?

Dual Lumen 5Fr HydroPICC Catheter (PICC-251CM) (PICC-251CM); Dual Lumen 5Fr HydroPICC Catheter (PICC-252CM) (PICC-252CM) received FDA 510(k) clearance on 2025-07-01, under 510(k) number K251212.

Who is the listed applicant for Dual Lumen 5Fr HydroPICC Catheter (PICC-251CM) (PICC-251CM); Dual Lumen 5Fr HydroPICC Catheter (PICC-252CM) (PICC-252CM)?

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 Dual Lumen 5Fr HydroPICC Catheter (PICC-251CM) (PICC-251CM); Dual Lumen 5Fr HydroPICC Catheter (PICC-252CM) (PICC-252CM)?

The FDA product code for Dual Lumen 5Fr HydroPICC Catheter (PICC-251CM) (PICC-251CM); Dual Lumen 5Fr HydroPICC Catheter (PICC-252CM) (PICC-252CM) is LJS.

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 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）K220772HydroMID 4F單腔中線導管 K213550HydroPICC 5F雙腔導管 K203069水MID

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相關器械（代碼：LJS）

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。

K260929Neonav 心電圖針定位系統Navi Medical Technologies K252373生物飛萊混合型PICC配備ENDEXO技術及PASV閥技術；生物飛萊PICC配備ENDEXO技術及PASV閥技術；生物飛萊PICC配備ENDEXO技術；生物飛萊中線針管；Xcela電漿注射型PICC；Xcela PICC配備PASV閥技術；Xcela混合型PICC配備PASV閥技術Spectrum Vascular K252792PM2™ 系統搭配 ECGuide™ 接頭Piccolo Medical, Inc.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）；HydrAccess Vascular, Inc.K243484PM2+系統及SmartPICC針筒Piccolo Medical, Inc.K241587飛行員TLSVygon Corporation

官方來源

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