FDA 510(k)

耐久全覆蓋食道支架系統

K 號：K251265 · 2025-07-23

決定日期2025-07-23

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

Resilience Fully Covered Esophageal Stent System is the device name listed in this FDA 510(k) record. The listed applicant is Merit Medical Systems, Inc.. It received FDA 510(k) clearance on 2025-07-23 under 510(k) number K251265. 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 Resilience Fully Covered Esophageal Stent System?

Resilience Fully Covered Esophageal Stent System is a medical device that received FDA 510(k) clearance on 2025-07-23. The listed applicant is Merit Medical Systems, Inc.. The 510(k) number is K251265.

When did Resilience Fully Covered Esophageal Stent System receive FDA 510(k) clearance?

Resilience Fully Covered Esophageal Stent System received FDA 510(k) clearance on 2025-07-23, under 510(k) number K251265.

Who is the listed applicant for Resilience Fully Covered Esophageal Stent System?

FDA 510(k) 記錄將 Merit Medical Systems, Inc. 列為申請人。這並不單獨確立設備製造商。

What is the FDA product code for Resilience Fully Covered Esophageal Stent System?

The FDA product code for Resilience Fully Covered Esophageal Stent System is ESW.

其他以 Merit Medical Systems, 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。

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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.K233939超柔靜食道內氣管支架系統；壁柔靜食道支架系統Boston Scientific 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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