FDA 510(k)

Compass BDS 胆管支架

K号: K213946 · 2022-05-09

决定日期2022-05-09

产品代码FGE

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决定实质等同

器械摘要

Compass BDS Biliary Stent is the device name listed in this FDA 510(k) record. The listed applicant is Cook Ireland, Ltd.. It received FDA 510(k) clearance on 2022-05-09 under 510(k) number K213946. The device is classified under product code FGE. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Compass BDS Biliary Stent?

Compass BDS Biliary Stent is a medical device that received FDA 510(k) clearance on 2022-05-09. The listed applicant is Cook Ireland, Ltd.. The 510(k) number is K213946.

When did Compass BDS Biliary Stent receive FDA 510(k) clearance?

Compass BDS Biliary Stent received FDA 510(k) clearance on 2022-05-09, under 510(k) number K213946.

Who is the listed applicant for Compass BDS Biliary Stent?

FDA 510(k)记录中列出Cook Ireland, Ltd.为申请人。这本身并不能确立该设备的制造商。

What is the FDA product code for Compass BDS Biliary Stent?

The FDA product code for Compass BDS Biliary Stent is FGE.

列明Cook Ireland, Ltd.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。

K261274EchoTip Ultra® 内镜超声活检针，适用于富士胶片内窥镜；EchoTip ProCore® 内镜超声活检针，适用于富士胶片内窥镜 K241209EchoTip AcuCore™ EUS 细胞活检针 (ECHO-BX-19)K233079Zimmon® 胰腺支架/支架套装（SPSOF，SPSOS，ZEPDF，ZEPDS，ZPSOF，ZPSOS）；Geenen® 胰腺支架/支架套装（GEPD，GPDS，GPSO，GPSOS）；Johlin® 胰腺楔形支架和导引器套装（JPWS）；推送导管和导引导管（GC，PC）；Geenen® Sof-Flex® 胰腺支架（GPSO-SF，GPSOS-SF）K230909EchoTip® AcuCore™ 超声活检针 (ECHO-BX-3-22)K210476EchoTip Ultra 内镜超声针，EchoTip ProCore HD 超声活检针，EchoTip Ultra 内镜支气管高清晰度超声针，EchoTip ProCore 内镜支气管高清晰度活检针 K182980Zilver 518 胆管支架，Zilver 635 胆管支架

查看所有 16 个设备 →

相关器械（代码：FGE）

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。

K254179引流导管Canyon Medical, Inc.K262913Protégé™ EverFlex™ 自膨胀外周支架系统Medtronic, Inc.K260835阿基米德可生物降解支架（中号）Q3 Medical USA, LLC (C/O Q3 Medical Devices Ltd.)K253393一次性球囊扩张导管（AG-5251-083018 AG-5251-085518 AG-5251-088018 AG-5251-083019 AG-5251-085519 AG-5251-088019 AG-5251-083021 AG-5251-085521 AG-5251-088021 AG-5251-083024 AG-5251-085524 AG-5251-088024 AG-5251-103018 AG-5251-105518 AG-5251-108018 AG-5251-103019 AG-5251-105519 AG-5251-108019 AG-5251-103021 AG-5251-105521 AG-5251-108021 AG-5251-103024 AG-5251-105524 AG-5251-108024 AG-5251-123018 AG-5251-125518 AG-5251-128018 AG-5251-123019 AG-5251-125519 AG-5251-128019）Hangzhou AGS MedTech Co., Ltd.K253832扩张球囊导管Mirco-Tech (Nanjing) Co., Ltd.K251658Endoflux® 胆管与胰腺支架套装Medi-Globe GmbH

官方来源

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