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FDA 510(k)

庫克-科普迴路腎盂造口套件，超膠劑腎盂造口套件配麥洛克，超膠劑會陰造口套件配麥洛克

K 號：K191498 · 2020-01-29

申請人Cook Incorporated
決定日期2020-01-29
產品代碼LJE
決定Unknown

器材摘要

Cook-Cope Loop Nephrostomy Set, Ultrathane Nephrostomy Set with Mac-Loc, Ultrathane Suprapubic Set with Mac-Loc is the device name listed in this FDA 510(k) record. The listed applicant is Cook Incorporated. It received FDA 510(k) clearance on 2020-01-29 under 510(k) number K191498. The device is classified under product code LJE. FDA Decision: Unknown.

常見問題

What is the Cook-Cope Loop Nephrostomy Set, Ultrathane Nephrostomy Set with Mac-Loc, Ultrathane Suprapubic Set with Mac-Loc?

Cook-Cope Loop Nephrostomy Set, Ultrathane Nephrostomy Set with Mac-Loc, Ultrathane Suprapubic Set with Mac-Loc is a medical device that received FDA 510(k) clearance on 2020-01-29. The listed applicant is Cook Incorporated. The 510(k) number is K191498.

When did Cook-Cope Loop Nephrostomy Set, Ultrathane Nephrostomy Set with Mac-Loc, Ultrathane Suprapubic Set with Mac-Loc receive FDA 510(k) clearance?

Cook-Cope Loop Nephrostomy Set, Ultrathane Nephrostomy Set with Mac-Loc, Ultrathane Suprapubic Set with Mac-Loc received FDA 510(k) clearance on 2020-01-29, under 510(k) number K191498.

Who is the listed applicant for Cook-Cope Loop Nephrostomy Set, Ultrathane Nephrostomy Set with Mac-Loc, Ultrathane Suprapubic Set with Mac-Loc?

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

What is the FDA product code for Cook-Cope Loop Nephrostomy Set, Ultrathane Nephrostomy Set with Mac-Loc, Ultrathane Suprapubic Set with Mac-Loc?

The FDA product code for Cook-Cope Loop Nephrostomy Set, Ultrathane Nephrostomy Set with Mac-Loc, Ultrathane Suprapubic Set with Mac-Loc is LJE.

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。

NCT07608549FLASH 預試階段 1 安全性研究NOT_YET_RECRUITINGNCT06562205PAP系統外部臨床研究（ECS）NOT_YET_RECRUITINGNCT06443177對於動脈瘤性硬腦膜下出血引起的腦血管收縮，交感調節的影響SUSPENDEDNCT07095751人工智能協助的Uro-Cam導尿管評估系統，用於診斷膀胱癌NOT_YET_RECRUITING

其他以 Cook Incorporated 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。

K233177Nest VT 液化設備K222254蓮花Vena Cava Filter 取出組K223098巴克里基本產後氣球K210734內血管擴張器及套件K203670超大檢查通導管K190903羅森逆行性腎盂造口針刺套件

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相關器械（代碼：LJE）

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。

K250448一次性經皮腎盂穿刺擴張套件Shenzhen Trious Medical Technology Co., Ltd.K222705導入針Youcare Technology Co.,Ltd. (Wuhan)K211911Kolibri 皮膚穿刺腎盂造口管，Kolibri 皮膚穿刺腎盂造口套件，Kolibri 直接穿刺套件Coloplast Corp.K201165In-Ka 皮膚穿刺球囊擴張針，Ampatz 套管Coloplast Corp.K190903羅森逆行性腎盂造口針刺套件Cook IncorporatedK183051凱伊腎盂造口充氣球囊導管及支架組Cook Incorporated

官方來源

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