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FDA 510(k)

WallFlex Biliary RX 網狀支架系統;Epic Biliary 網狀支架系統;WallFlex Biliary RX 全覆蓋網狀支架系統 RMV

K 號:K240464 · 2024-08-30

決定日期2024-08-30
產品代碼FGE
諮詢委員會GU
決定Unknown

器材摘要

WallFlex Biliary RX Stent System; Epic Biliary Stent System; WallFlex Biliary RX Fully Covered Stent System RMV is the device name listed in this FDA 510(k) record. The listed applicant is Boston Scientific. It received FDA 510(k) clearance on 2024-08-30 under 510(k) number K240464. The device is classified under product code FGE. It was reviewed by the GU advisory panel. FDA Decision: Unknown.

常見問題

What is the WallFlex Biliary RX Stent System; Epic Biliary Stent System; WallFlex Biliary RX Fully Covered Stent System RMV?

WallFlex Biliary RX Stent System; Epic Biliary Stent System; WallFlex Biliary RX Fully Covered Stent System RMV is a medical device that received FDA 510(k) clearance on 2024-08-30. The listed applicant is Boston Scientific. The 510(k) number is K240464.

When did WallFlex Biliary RX Stent System; Epic Biliary Stent System; WallFlex Biliary RX Fully Covered Stent System RMV receive FDA 510(k) clearance?

WallFlex Biliary RX Stent System; Epic Biliary Stent System; WallFlex Biliary RX Fully Covered Stent System RMV received FDA 510(k) clearance on 2024-08-30, under 510(k) number K240464.

Who is the listed applicant for WallFlex Biliary RX Stent System; Epic Biliary Stent System; WallFlex Biliary RX Fully Covered Stent System RMV?

FDA 510(k) 記錄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 Biliary RX Stent System; Epic Biliary Stent System; WallFlex Biliary RX Fully Covered Stent System RMV?

The FDA product code for WallFlex Biliary RX Stent System; Epic Biliary Stent System; WallFlex Biliary RX Fully Covered Stent System RMV is FGE.

相關臨床試驗

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其他以 Boston Scientific 為申請人之記錄

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相關器械(代碼:FGE)

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。

官方來源

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