FDA 510(k)

超柔靜食道內氣管支架系統；壁柔靜食道支架系統

K 號：K233939 · 2024-04-29

決定日期2024-04-29

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

Ultraflex Esophageal NG Stent System; WallFlex Esophageal Stent System is the device name listed in this FDA 510(k) record. The listed applicant is Boston Scientific. It received FDA 510(k) clearance on 2024-04-29 under 510(k) number K233939. 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 Ultraflex Esophageal NG Stent System; WallFlex Esophageal Stent System?

Ultraflex Esophageal NG Stent System; WallFlex Esophageal Stent System is a medical device that received FDA 510(k) clearance on 2024-04-29. The listed applicant is Boston Scientific. The 510(k) number is K233939.

When did Ultraflex Esophageal NG Stent System; WallFlex Esophageal Stent System receive FDA 510(k) clearance?

Ultraflex Esophageal NG Stent System; WallFlex Esophageal Stent System received FDA 510(k) clearance on 2024-04-29, under 510(k) number K233939.

Who is the listed applicant for Ultraflex Esophageal NG Stent System; WallFlex Esophageal Stent System?

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 Ultraflex Esophageal NG Stent System; WallFlex Esophageal Stent System?

The FDA product code for Ultraflex Esophageal NG Stent System; WallFlex Esophageal Stent System is ESW.

其他以 Boston Scientific 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。

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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 K253327HANAROSTENT 食道上段 (CCC)M.I.Tech Co., Ltd.K243619Niti-S 食管支架；食管TTS支架Taewoong Medical Co., Ltd.K251265耐久全覆蓋食道支架系統Merit Medical Systems, Inc.K233837Agile 食管支架系統Boston Scientific Corporation K240522食道TTS支架Taewoong Medical

官方來源

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