FDA 510(k)

想像矽膠雙環輸尿管支架

K 號：K180469 · 2018-11-06

決定日期2018-11-06

產品代碼FAD

諮詢委員會GU

決定相當於

器材摘要

ImaJin Silicone Hydro-Coated Double Loop Ureteral Stent is the device name listed in this FDA 510(k) record. The listed applicant is Coloplast Corp.. It received FDA 510(k) clearance on 2018-11-06 under 510(k) number K180469. The device is classified under product code FAD. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the ImaJin Silicone Hydro-Coated Double Loop Ureteral Stent?

ImaJin Silicone Hydro-Coated Double Loop Ureteral Stent is a medical device that received FDA 510(k) clearance on 2018-11-06. The listed applicant is Coloplast Corp.. The 510(k) number is K180469.

When did ImaJin Silicone Hydro-Coated Double Loop Ureteral Stent receive FDA 510(k) clearance?

ImaJin Silicone Hydro-Coated Double Loop Ureteral Stent received FDA 510(k) clearance on 2018-11-06, under 510(k) number K180469.

Who is the listed applicant for ImaJin Silicone Hydro-Coated Double Loop Ureteral Stent?

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

What is the FDA product code for ImaJin Silicone Hydro-Coated Double Loop Ureteral Stent?

The FDA product code for ImaJin Silicone Hydro-Coated Double Loop Ureteral Stent is FAD.

其他以 Coloplast Corp. 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：FAD）

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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