FDA 510(k)

ARCHIMEDES 生物可降解胰臟支架

K 號：K243412 · 2025-07-16

申請人Q3 Medical USA, LLC (C/O Q3 Medical Devices Ltd.)

決定日期2025-07-16

產品代碼FGE

諮詢委員會GU

決定相當於

器材摘要

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.

常見問題

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) 記錄將 Q3 Medical USA, LLC（C/O Q3 Medical Devices Ltd.）列為申請人。這並不單獨確立設備製造商。

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

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

其他以 Q3 Medical USA, LLC (C/O Q3 Medical Devices Ltd.) 為申請人之記錄

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

K260835阿基米德可生物降解支架（中號）

相關器械（代碼：FGE）

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

K254179引流針管Canyon Medical, Inc.K262913Protégé™ EverFlex™ 自擴張週邊支架系統Medtronic, Inc.K260835阿基米德可生物降解支架（中號）Q3 Medical USA, LLC (C/O Q3 Medical Devices Ltd.)K253393單次使用氣球擴張導管（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擴張氣球心导管Mirco-Tech (Nanjing) Co., Ltd.K251658Endoflux™ 胆胰支架組Medi-Globe GmbH

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