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FDA 510(k)

BARE 导丝引导球囊扩张导管（1235）

K号: K253987 · 2026-03-13

申请人GIE Medical
决定日期2026-03-13
产品代码FGE
咨询委员会GU 请注意，由于您只提供了“GU”这个词，我无法提供完整的翻译。如果您能提供完整的句子或段落，我将能够为您提供准确的翻译。
决定实质等同

器械摘要

BARE Wireguided Balloon Dilation Catheter (1235) is the device name listed in this FDA 510(k) record. The listed applicant is GIE Medical. It received FDA 510(k) clearance on 2026-03-13 under 510(k) number K253987. 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 BARE Wireguided Balloon Dilation Catheter (1235)?

BARE Wireguided Balloon Dilation Catheter (1235) is a medical device that received FDA 510(k) clearance on 2026-03-13. The listed applicant is GIE Medical. The 510(k) number is K253987.

When did BARE Wireguided Balloon Dilation Catheter (1235) receive FDA 510(k) clearance?

BARE Wireguided Balloon Dilation Catheter (1235) received FDA 510(k) clearance on 2026-03-13, under 510(k) number K253987.

Who is the listed applicant for BARE Wireguided Balloon Dilation Catheter (1235)?

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

What is the FDA product code for BARE Wireguided Balloon Dilation Catheter (1235)?

The FDA product code for BARE Wireguided Balloon Dilation Catheter (1235) is FGE.

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。

NCT07608549FLASHPilot 1期安全性研究NOT_YET_RECRUITINGNCT06562205PAP系统外部临床研究（ECS）NOT_YET_RECRUITINGNCT06443177交感神经调节对动脉瘤性蛛网膜下腔出血继发脑动脉痉挛的影响SUSPENDEDNCT07095751人工智能辅助尿路摄像头评估系统，用于诊断膀胱癌NOT_YET_RECRUITING

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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