FDA 510(k)

進化十二指腸支架系統 - 開放式，進化結腸支架系統 - 開放式

K 號：K163468 · 2017-05-04

決定日期2017-05-04

產品代碼MUM

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

Evolution Duodenal Stent System - Uncovered, Evolution Colonic Stent System - Uncovered is the device name listed in this FDA 510(k) record. The listed applicant is Cook Ireland, Ltd.. It received FDA 510(k) clearance on 2017-05-04 under 510(k) number K163468. The device is classified under product code MUM. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Evolution Duodenal Stent System - Uncovered, Evolution Colonic Stent System - Uncovered?

Evolution Duodenal Stent System - Uncovered, Evolution Colonic Stent System - Uncovered is a medical device that received FDA 510(k) clearance on 2017-05-04. The listed applicant is Cook Ireland, Ltd.. The 510(k) number is K163468.

When did Evolution Duodenal Stent System - Uncovered, Evolution Colonic Stent System - Uncovered receive FDA 510(k) clearance?

Evolution Duodenal Stent System - Uncovered, Evolution Colonic Stent System - Uncovered received FDA 510(k) clearance on 2017-05-04, under 510(k) number K163468.

Who is the listed applicant for Evolution Duodenal Stent System - Uncovered, Evolution Colonic Stent System - Uncovered?

FDA 510(k) 記錄將 Cook Ireland, Ltd. 列為申請人。這並不單獨確立設備製造商。

What is the FDA product code for Evolution Duodenal Stent System - Uncovered, Evolution Colonic Stent System - Uncovered?

The FDA product code for Evolution Duodenal Stent System - Uncovered, Evolution Colonic Stent System - Uncovered is MUM.

其他以 Cook Ireland, Ltd. 為申請人之記錄

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相關器械（代碼：MUM）

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。

K250663Niti-S 十二指腸舒適支架，Niti-S 大腸舒適支架Taewoong Medical Co., Ltd.K223067Niti-S Duodenal Stent; Niti-S Colonic Comfort StentTaewoong Medical Co., Ltd.

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。