FDA 510(k)

ARCHIMEDES生物可降解胰腺支架

K号: K243412 · 2025-07-16

申请人Q3 Medical USA, LLC (C/O Q3 Medical Devices Ltd.)

决定日期2025-07-16

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

ARCHIMEDES Biodegradable Pancreatic Stent is the device name listed in this FDA 510(k) record. The listed applicant is Q3 Medical USA, LLC (C/O Q3 Medical Devices Ltd.). It received FDA 510(k) clearance on 2025-07-16 under 510(k) number K243412. 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 ARCHIMEDES Biodegradable Pancreatic Stent?

ARCHIMEDES Biodegradable Pancreatic Stent is a medical device that received FDA 510(k) clearance on 2025-07-16. The listed applicant is Q3 Medical USA, LLC (C/O Q3 Medical Devices Ltd.). The 510(k) number is K243412.

When did ARCHIMEDES Biodegradable Pancreatic Stent receive FDA 510(k) clearance?

ARCHIMEDES Biodegradable Pancreatic Stent received FDA 510(k) clearance on 2025-07-16, under 510(k) number K243412.

Who is the listed applicant for ARCHIMEDES Biodegradable Pancreatic Stent?

FDA 510(k)记录将Q3 Medical USA, LLC（C/O Q3 Medical Devices Ltd.）列为申请人。这本身并不足以确立该设备的制造商。

What is the FDA product code for ARCHIMEDES Biodegradable Pancreatic Stent?

The FDA product code for ARCHIMEDES Biodegradable Pancreatic Stent is FGE.

列明Q3 Medical USA, LLC (C/O Q3 Medical Devices 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。

K260835阿基米德可生物降解支架（中号）

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

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