FDA 510(k)

ConvertX 胆管支架系統

K 號：K181669 · 2019-03-14

決定日期2019-03-14

產品代碼FGE

諮詢委員會GU

決定相當於

器材摘要

ConvertX Biliary Stent System is the device name listed in this FDA 510(k) record. The listed applicant is Brightwater Medical. It received FDA 510(k) clearance on 2019-03-14 under 510(k) number K181669. The device is classified under product code FGE. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the ConvertX Biliary Stent System?

ConvertX Biliary Stent System is a medical device that received FDA 510(k) clearance on 2019-03-14. The listed applicant is Brightwater Medical. The 510(k) number is K181669.

When did ConvertX Biliary Stent System receive FDA 510(k) clearance?

ConvertX Biliary Stent System received FDA 510(k) clearance on 2019-03-14, under 510(k) number K181669.

Who is the listed applicant for ConvertX Biliary Stent System?

The FDA 510(k) record lists Brightwater Medical as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ConvertX Biliary Stent System?

The FDA product code for ConvertX Biliary Stent System is FGE.

其他以 Brightwater Medical 為申請人之記錄

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K161277ConvertX 腎盂輸尿管支架系統

相關器械（代碼：FGE）

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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