食道TTS支架
K 號：K240522 · 2024-03-22
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器材摘要
Esophageal TTS Stent is the device name listed in this FDA 510(k) record. The listed applicant is Taewoong Medical. It received FDA 510(k) clearance on 2024-03-22 under 510(k) number K240522. 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 Esophageal TTS Stent?
Esophageal TTS Stent is a medical device that received FDA 510(k) clearance on 2024-03-22. The listed applicant is Taewoong Medical. The 510(k) number is K240522.
When did Esophageal TTS Stent receive FDA 510(k) clearance?
Esophageal TTS Stent received FDA 510(k) clearance on 2024-03-22, under 510(k) number K240522.
Who is the listed applicant for Esophageal TTS Stent?
The FDA 510(k) record lists Taewoong Medical as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Esophageal TTS Stent?
The FDA product code for Esophageal TTS Stent is ESW.
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。
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 CorporationK253327HANAROSTENT 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.K233939超柔靜食道內氣管支架系統；壁柔靜食道支架系統Boston ScientificK233837Agile 食管支架系統Boston Scientific Corporation
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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