FDA 510(k)

凱伊腎盂造口充氣球囊導管及支架組

K 號：K183051 · 2019-07-16

決定日期2019-07-16

產品代碼LJE

決定Unknown

器材摘要

Kaye Nephrostomy Tamponade Balloon Catheter and Stent Set is the device name listed in this FDA 510(k) record. The listed applicant is Cook Incorporated. It received FDA 510(k) clearance on 2019-07-16 under 510(k) number K183051. The device is classified under product code LJE. FDA Decision: Unknown.

常見問題

What is the Kaye Nephrostomy Tamponade Balloon Catheter and Stent Set?

Kaye Nephrostomy Tamponade Balloon Catheter and Stent Set is a medical device that received FDA 510(k) clearance on 2019-07-16. The listed applicant is Cook Incorporated. The 510(k) number is K183051.

When did Kaye Nephrostomy Tamponade Balloon Catheter and Stent Set receive FDA 510(k) clearance?

Kaye Nephrostomy Tamponade Balloon Catheter and Stent Set received FDA 510(k) clearance on 2019-07-16, under 510(k) number K183051.

Who is the listed applicant for Kaye Nephrostomy Tamponade Balloon Catheter and Stent Set?

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 Kaye Nephrostomy Tamponade Balloon Catheter and Stent Set?

The FDA product code for Kaye Nephrostomy Tamponade Balloon Catheter and Stent Set is LJE.

其他以 Cook Incorporated 為申請人之記錄

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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.K191498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Cook Incorporated K190903羅森逆行性腎盂造口針刺套件Cook Incorporated

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