FDA 510(k)

SmartPort+ 埋植式港道，SmartPort 塑膠埋植式港道

K 號：K190559 · 2020-05-22

決定日期2020-05-22

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

SmartPort+ Implantable Ports, SmartPort Plastic Implantable Ports is the device name listed in this FDA 510(k) record. The listed applicant is AngioDynamics, Inc.. It received FDA 510(k) clearance on 2020-05-22 under 510(k) number K190559. 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 SmartPort+ Implantable Ports, SmartPort Plastic Implantable Ports?

SmartPort+ Implantable Ports, SmartPort Plastic Implantable Ports is a medical device that received FDA 510(k) clearance on 2020-05-22. The listed applicant is AngioDynamics, Inc.. The 510(k) number is K190559.

When did SmartPort+ Implantable Ports, SmartPort Plastic Implantable Ports receive FDA 510(k) clearance?

SmartPort+ Implantable Ports, SmartPort Plastic Implantable Ports received FDA 510(k) clearance on 2020-05-22, under 510(k) number K190559.

Who is the listed applicant for SmartPort+ Implantable Ports, SmartPort Plastic Implantable Ports?

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

What is the FDA product code for SmartPort+ Implantable Ports, SmartPort Plastic Implantable Ports?

The FDA product code for SmartPort+ Implantable Ports, SmartPort Plastic Implantable Ports is LJT.

其他以 AngioDynamics, 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。

K252509AlphaVac 多功能機械吸引系統 F1885 K253106AngioVac 管套 K242687NanoKnife 產生器 (H78720300301US0)；NanoKnife 獨一電極啟動探針，15 cm (H787204001090)；NanoKnife 獨一電極啟動探針，25 cm (H787204001100)；NanoKnife 獨一電極探針間隔器 (H787204003010)K240397AlphaVac MMA F1885 系統 (H787253020)K231945VenaCure EVLT NeverTouch 手術套件；VenaCure EVLT NeverTouch 直接手術套件 K223581索勒爾微波組織消融（MTA）系統及附件

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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.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.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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