FDA 510(k)

Agile 食管支架系統

K 號：K233837 · 2024-04-04

決定日期2024-04-04

產品代碼ESW

諮詢委員會SU 請提供完整的描述文本，以便我進行翻譯。

決定相當於

器材摘要

Agile Esophageal Stent System is the device name listed in this FDA 510(k) record. The listed applicant is Boston Scientific Corporation. It received FDA 510(k) clearance on 2024-04-04 under 510(k) number K233837. The device is classified under product code ESW. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Agile Esophageal Stent System?

Agile Esophageal Stent System is a medical device that received FDA 510(k) clearance on 2024-04-04. The listed applicant is Boston Scientific Corporation. The 510(k) number is K233837.

When did Agile Esophageal Stent System receive FDA 510(k) clearance?

Agile Esophageal Stent System received FDA 510(k) clearance on 2024-04-04, under 510(k) number K233837.

Who is the listed applicant for Agile Esophageal Stent System?

FDA 510(k) 記錄中將波士頓科學公司列為申請人。這並不單獨確立設備製造商。

What is the FDA product code for Agile Esophageal Stent System?

The FDA product code for Agile Esophageal Stent System is ESW.

其他以 Boston Scientific Corporation 為申請人之記錄

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K262151SpaceOAR Flex™ 系統 K261153LithoVue Elite數位柔軟輸尿管鏡系統 K261915導航™ Flex 腎管進入鞘組合 K262165FARADRIVE™操縱式鞘 (M004PF21M402)K262462TheraSphere 360™ Y-90 管理平台 K261488OBSIDIO 可調適性栓塊

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相關器械（代碼：ESW）

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。

K261978WallFlex 食道支架系統；Agile 食道穿過導管（OTW）支架系統Boston Scientific Corporation K243619Niti-S 食管支架；食管TTS支架Taewoong Medical Co., Ltd.K253327HANAROSTENT 食道上段 (CCC)M.I.Tech Co., Ltd.K251265耐久全覆蓋食道支架系統Merit Medical Systems, Inc.K233939超柔靜食道內氣管支架系統；壁柔靜食道支架系統Boston Scientific K240522食道TTS支架Taewoong Medical

官方來源

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