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FDA 510(k)

WallFlex 大腸支架系統搭配錨點釋放系統；WallFlex 十二指腸支架系統搭配錨點釋放系統；WallFlex 大腸柔軟支架系統搭配錨點釋放系統；WallFlex 十二指腸柔軟支架系統搭配錨點釋放系統

K 號：K234046 · 2024-03-08

申請人Boston Scientific Corporation
決定日期2024-03-08
產品代碼MQR
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

WallFlex Colonic Stent System with Anchor Lock Delivery System; WallFlex Duodenal Stent System with Anchor Lock Delivery System; WallFlex Colonic Soft Stent System with Anchor Lock Delivery System; WallFlex Duodenal Soft Stent System with Anchor Lock Delivery 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 2024-03-08 under 510(k) number K234046. The device is classified under product code MQR. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the WallFlex Colonic Stent System with Anchor Lock Delivery System; WallFlex Duodenal Stent System with Anchor Lock Delivery System; WallFlex Colonic Soft Stent System with Anchor Lock Delivery System; WallFlex Duodenal Soft Stent System with Anchor Lock Delivery System?

WallFlex Colonic Stent System with Anchor Lock Delivery System; WallFlex Duodenal Stent System with Anchor Lock Delivery System; WallFlex Colonic Soft Stent System with Anchor Lock Delivery System; WallFlex Duodenal Soft Stent System with Anchor Lock Delivery System is a medical device that received FDA 510(k) clearance on 2024-03-08. The listed applicant is Boston Scientific Corporation. The 510(k) number is K234046.

When did WallFlex Colonic Stent System with Anchor Lock Delivery System; WallFlex Duodenal Stent System with Anchor Lock Delivery System; WallFlex Colonic Soft Stent System with Anchor Lock Delivery System; WallFlex Duodenal Soft Stent System with Anchor Lock Delivery System receive FDA 510(k) clearance?

WallFlex Colonic Stent System with Anchor Lock Delivery System; WallFlex Duodenal Stent System with Anchor Lock Delivery System; WallFlex Colonic Soft Stent System with Anchor Lock Delivery System; WallFlex Duodenal Soft Stent System with Anchor Lock Delivery System received FDA 510(k) clearance on 2024-03-08, under 510(k) number K234046.

Who is the listed applicant for WallFlex Colonic Stent System with Anchor Lock Delivery System; WallFlex Duodenal Stent System with Anchor Lock Delivery System; WallFlex Colonic Soft Stent System with Anchor Lock Delivery System; WallFlex Duodenal Soft Stent System with Anchor Lock Delivery 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 WallFlex Colonic Stent System with Anchor Lock Delivery System; WallFlex Duodenal Stent System with Anchor Lock Delivery System; WallFlex Colonic Soft Stent System with Anchor Lock Delivery System; WallFlex Duodenal Soft Stent System with Anchor Lock Delivery System?

The FDA product code for WallFlex Colonic Stent System with Anchor Lock Delivery System; WallFlex Duodenal Stent System with Anchor Lock Delivery System; WallFlex Colonic Soft Stent System with Anchor Lock Delivery System; WallFlex Duodenal Soft Stent System with Anchor Lock Delivery System is MQR.

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。

NCT07608549FLASH 預試階段 1 安全性研究NOT_YET_RECRUITINGNCT06562205PAP系統外部臨床研究（ECS）NOT_YET_RECRUITINGNCT06443177對於動脈瘤性硬腦膜下出血引起的腦血管收縮，交感調節的影響SUSPENDEDNCT07095751人工智能協助的Uro-Cam導尿管評估系統，用於診斷膀胱癌NOT_YET_RECRUITING

其他以 Boston Scientific Corporation 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。

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：MQR）

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。

K201159WallFlex 大腸支架系統搭配錨點釋放系統Boston Scientific CorporationK200257WallFlex 大腸柔軟支架系統搭配錨點鎖釋放系統，WallFlex 十二指腸柔軟支架系統搭配錨點鎖釋放系統Boston Scientific CorporationK190141HANAROSTENT 低擴張直腸/乙狀结肠 (NNN)M.I.Tech Co., Ltd.K183616HANAROSTENT 低擴張 大腸/直腸 (NNN)，HANAROSTENT 低擴張 十二指腸/幽門 (NNN)M.I.Tech Co., Ltd.K180180HANAROSTENT 低AxTM 大腸/直腸 (NNN)，HANAROSTENT 低AxTM 十二指腸/幽門 (NNN)M.I.Tech Co., Ltd.

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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