FDA 510(k)

Zilver 518TM 胆管支架；Zilver 635TM 胆管支架

K 號：K163169 · 2017-02-07

決定日期2017-02-07

產品代碼FGE

諮詢委員會GU

決定Unknown

器材摘要

Zilver 518TM Biliary Stent; Zilver 635TM 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 2017-02-07 under 510(k) number K163169. The device is classified under product code FGE. It was reviewed by the GU advisory panel. FDA Decision: Unknown.

常見問題

What is the Zilver 518TM Biliary Stent; Zilver 635TM Biliary Stent?

Zilver 518TM Biliary Stent; Zilver 635TM Biliary Stent is a medical device that received FDA 510(k) clearance on 2017-02-07. The listed applicant is Cook Ireland, Ltd.. The 510(k) number is K163169.

When did Zilver 518TM Biliary Stent; Zilver 635TM Biliary Stent receive FDA 510(k) clearance?

Zilver 518TM Biliary Stent; Zilver 635TM Biliary Stent received FDA 510(k) clearance on 2017-02-07, under 510(k) number K163169.

Who is the listed applicant for Zilver 518TM Biliary Stent; Zilver 635TM Biliary Stent?

FDA 510(k) 記錄將 Cook Ireland, 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 Zilver 518TM Biliary Stent; Zilver 635TM Biliary Stent?

The FDA product code for Zilver 518TM Biliary Stent; Zilver 635TM Biliary Stent is FGE.

其他以 Cook Ireland, 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。

K261274EchoTip Ultra® 高解析度內視鏡超聲針對 Fujifilm 鏡頭；EchoTip ProCore® 高解析度內視鏡超聲針對 Fujifilm 鏡頭 K241209EchoTip AcuCore™ EUS 結締針 (ECHO-BX-19)K233079Zimmon® 胰腺支架/支架組（SPSOF、SPSOS、ZEPDF、ZEPDS、ZPSOF、ZPSOS）；Geenen® 胰腺支架/支架組（GEPD、GPDS、GPSO、GPSOS）；Johlin® 胰腺楔形支架及導入組（JPWS）；推入式導管及導引式導管（GC、PC）；Geenen® Sof-Flex® 胰腺支架（GPSO-SF、GPSOS-SF）K230909EchoTip® AcuCore™ 超聲波針吸針 (ECHO-BX-3-22)K213946Compass BDS 胆道支架 K210476EchoTip Ultra內視鏡超聲針，EchoTip ProCore HD超聲針吸組織切片，EchoTip Ultra內支氣管高解析度超聲針，EchoTip ProCore內支氣管高解析度超聲針吸組織切片

查看所有 16 項裝置 →

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

官方來源

在 FDA 資料庫中查看 →

資料來源為 FDA Open API。如需最新且權威的資訊，請始終參閱官方記錄。