FDA 510(k)

PowerPort™ ClearVUE™ 瘦型植入式港道及PowerPort™ ClearVUE™ 瘦型植入式港道

K 號：K242328 · 2024-10-31

決定日期2024-10-31

產品代碼LJT

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

PowerPort™ ClearVUE™ Slim Implantable Ports and PowerPort™ ClearVUE™ Slim Implantable Ports is the device name listed in this FDA 510(k) record. The listed applicant is Bard Access Systems, Inc.. It received FDA 510(k) clearance on 2024-10-31 under 510(k) number K242328. The device is classified under product code LJT. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the PowerPort™ ClearVUE™ Slim Implantable Ports and PowerPort™ ClearVUE™ Slim Implantable Ports?

PowerPort™ ClearVUE™ Slim Implantable Ports and PowerPort™ ClearVUE™ Slim Implantable Ports is a medical device that received FDA 510(k) clearance on 2024-10-31. The listed applicant is Bard Access Systems, Inc.. The 510(k) number is K242328.

When did PowerPort™ ClearVUE™ Slim Implantable Ports and PowerPort™ ClearVUE™ Slim Implantable Ports receive FDA 510(k) clearance?

PowerPort™ ClearVUE™ Slim Implantable Ports and PowerPort™ ClearVUE™ Slim Implantable Ports received FDA 510(k) clearance on 2024-10-31, under 510(k) number K242328.

Who is the listed applicant for PowerPort™ ClearVUE™ Slim Implantable Ports and PowerPort™ ClearVUE™ Slim Implantable Ports?

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

What is the FDA product code for PowerPort™ ClearVUE™ Slim Implantable Ports and PowerPort™ ClearVUE™ Slim Implantable Ports?

The FDA product code for PowerPort™ ClearVUE™ Slim Implantable Ports and PowerPort™ ClearVUE™ Slim Implantable Ports is LJT.

其他以 Bard Access Systems, 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。

K252478Vaccess™ CT 低輪廓電漿注射式植入式港道；Vaccess™ CT 電漿注射式植入式港道；PowerPort™ duo M.R.I.™ 植入式港道 K251253PowerPort™ 嵌入式港；PowerPort™ 縮小嵌入式港；PowerPort™ M.R.I.™ 嵌入式港；PowerPort™ M.R.I.™ isp 嵌入式港 K241353PowerLoc™ Max 電漿注射輸液套組；SafeStep™ Huber 鋒針套組 K240146BD Prevue™ II 頸外周血管通路系統 K222232Sherlock 3CG® 結構定位系統 (TPS) 鋒針/T-Lock 製件 K210264BD PowerPiCC 線管

查看所有 7 項裝置 →

相關器械（代碼：LJT）

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。

K260916FLEXI-PORT™ 電擊注射式植入式港Portal Access, Inc.K252478Vaccess™ CT 低輪廓電漿注射式植入式港道；Vaccess™ CT 電漿注射式植入式港道；PowerPort™ duo M.R.I.™ 植入式港道Bard Access Systems, Inc.K251253PowerPort™ 嵌入式港；PowerPort™ 縮小嵌入式港；PowerPort™ M.R.I.™ 嵌入式港；PowerPort™ M.R.I.™ isp 嵌入式港Bard Access Systems, Inc.K232737PowerPort™ ClearVUE™ 瘦版心電圖啟用植入式端口；PowerPort™ isp ClearVUE™ 心電圖啟用植入式端口；PowerPort™ isp M.R.I.™ 心電圖啟用植入式端口；PowerPort™ 瘦版心電圖啟用植入式端口Bard Peripheral Vascular, Inc.K190559SmartPort+ 埋植式港道，SmartPort 塑膠埋植式港道AngioDynamics, Inc.K181446巴德電動注射式植入式港道（PowerPorts®）C.R. Bard, Inc.

官方來源

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