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FDA 510(k)

Cook-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-Loc

K号: K191498 · 2020-01-29

申请人Cook Incorporated
决定日期2020-01-29
产品代码LJE
决定Unknown

器械摘要

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.

常见问题

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.

相关临床试验

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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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.K190903Lawson 逆行肾造口钢丝穿刺套装Cook IncorporatedK183051Kaye肾造瘘冲洗球囊导管和支架套装Cook Incorporated

官方来源

在 FDA 数据库中查看 →

数据来源于FDA开放API。如需最新且权威的信息，请务必参考官方记录。

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