FDA 510(k)

Kaye肾造瘘冲洗球囊导管和支架套装

K号: K183051 · 2019-07-16

决定日期2019-07-16

产品代码LJE

决定Unknown

器械摘要

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.

常见问题

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.

列明Cook Incorporated为申报人的其他记录

关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。

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相关器械（代码：LJE）

关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。

K250448一次性经皮肾造口扩张套件Shenzhen Trious Medical Technology Co., Ltd.K222705引入针Youcare Technology Co.,Ltd. (Wuhan)K211911Kolibri 经皮肾造瘘导管，Kolibri 经皮肾造瘘套装，Kolibri 直接穿刺套装Coloplast Corp.K201165In-Ka Percutaneous Balloon Dilatation Catheters, Amplatz SheathColoplast Corp.K191498Cook-Cope 环形肾造口套装，Ultrathane 肾造口套装带 Mac-Loc，Ultrathane 腹股沟套装带 Mac-LocCook Incorporated K190903Lawson 逆行肾造口钢丝穿刺套装Cook Incorporated

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