超柔™ 氣管支氣管支架系統
K 號：K230269 · 2023-07-14
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器材摘要
Ultraflex™ Tracheobronchial Stent 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 2023-07-14 under 510(k) number K230269. The device is classified under product code JCT. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the Ultraflex™ Tracheobronchial Stent System?
Ultraflex™ Tracheobronchial Stent System is a medical device that received FDA 510(k) clearance on 2023-07-14. The listed applicant is Boston Scientific Corporation. The 510(k) number is K230269.
When did Ultraflex™ Tracheobronchial Stent System receive FDA 510(k) clearance?
Ultraflex™ Tracheobronchial Stent System received FDA 510(k) clearance on 2023-07-14, under 510(k) number K230269.
Who is the listed applicant for Ultraflex™ Tracheobronchial Stent 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 Ultraflex™ Tracheobronchial Stent System?
The FDA product code for Ultraflex™ Tracheobronchial Stent System is JCT.
相關臨床試驗
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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。
相關器械（代碼：JCT）
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。
K220424透過範圍氣管支架系統Micro-Tech (Nanjing) Co., Ltd.K212403氣管支架系統（Y型）Micro-Tech (Nanjing) Co., Ltd.K202204氣管支架系統Micro-Tech (Nanjing) Co., Ltd.K201342HANAROSTENT 氣管/支氣管（CCC）M.I.Tech Co., Ltd.K181200AEROmini 氣管支氣管支架系統Merit Medical Systems, Inc.K152842WALLSTENT RP內置支架氣管支氣管，WALLSTENT內置支架氣管支氣管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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