FLEXI-PORT™ 電擊注射式植入式港
K 號：K260916 · 2026-06-17
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決定日期2026-06-17
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
FLEXI-PORT™ Power Injectable Implantable Port is the device name listed in this FDA 510(k) record. The listed applicant is Portal Access, Inc.. It received FDA 510(k) clearance on 2026-06-17 under 510(k) number K260916. 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 FLEXI-PORT™ Power Injectable Implantable Port?
FLEXI-PORT™ Power Injectable Implantable Port is a medical device that received FDA 510(k) clearance on 2026-06-17. The listed applicant is Portal Access, Inc.. The 510(k) number is K260916.
When did FLEXI-PORT™ Power Injectable Implantable Port receive FDA 510(k) clearance?
FLEXI-PORT™ Power Injectable Implantable Port received FDA 510(k) clearance on 2026-06-17, under 510(k) number K260916.
Who is the listed applicant for FLEXI-PORT™ Power Injectable Implantable Port?
The FDA 510(k) record lists Portal Access, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for FLEXI-PORT™ Power Injectable Implantable Port?
The FDA product code for FLEXI-PORT™ Power Injectable Implantable Port is LJT.
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。
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。
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.K242328PowerPort™ ClearVUE™ 瘦型植入式港道及PowerPort™ ClearVUE™ 瘦型植入式港道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
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。
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