FDA 510(k)

Emboshield NAV6 體內栓子防護系統，裸線過濾導線

K 號：K191173 · 2019-07-25

決定日期2019-07-25

產品代碼NTE

諮詢委員會履歷

決定相當於

器材摘要

Emboshield NAV6 Embolic Protection System, Barewire Filter Delivery Wires is the device name listed in this FDA 510(k) record. The listed applicant is Abbott Vascular. It received FDA 510(k) clearance on 2019-07-25 under 510(k) number K191173. The device is classified under product code NTE. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Emboshield NAV6 Embolic Protection System, Barewire Filter Delivery Wires?

Emboshield NAV6 Embolic Protection System, Barewire Filter Delivery Wires is a medical device that received FDA 510(k) clearance on 2019-07-25. The listed applicant is Abbott Vascular. The 510(k) number is K191173.

When did Emboshield NAV6 Embolic Protection System, Barewire Filter Delivery Wires receive FDA 510(k) clearance?

Emboshield NAV6 Embolic Protection System, Barewire Filter Delivery Wires received FDA 510(k) clearance on 2019-07-25, under 510(k) number K191173.

Who is the listed applicant for Emboshield NAV6 Embolic Protection System, Barewire Filter Delivery Wires?

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

What is the FDA product code for Emboshield NAV6 Embolic Protection System, Barewire Filter Delivery Wires?

The FDA product code for Emboshield NAV6 Embolic Protection System, Barewire Filter Delivery Wires is NTE.

其他以 Abbott Vascular 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。

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相關器械（代碼：NTE）

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。

K222694EmPro EPS (EP4514C-190, EP6514C-190)；Nanoparasol EPS (PNP4514C-190, PNP6514C-190)MicroVention, Inc.K230402ENROUTE® 頸動脈神經保護系統Silk Road Medical K220654ANGIOGUARD XP 過濾導絲, ANGIOGUARD RX 過濾導絲Cordis Corporation K210282WIRION 體內栓塊防護系統Cardiovascular Systems, Inc.K200198WIRIONCardiovascular Systems, Inc.K180023WIRIONGardia Medical , Ltd.

官方來源

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