FDA 510(k)

AXIOS 支架及電灼輸送強化系統

K 號：K163272 · 2017-02-18

決定日期2017-02-18

產品代碼PCU

諮詢委員會GU

決定相當於

器材摘要

AXIOS Stent and Electrocautery Enhanced Delivery System is the device name listed in this FDA 510(k) record. The listed applicant is Boston Scientific Corporation. It received FDA 510(k) clearance on 2017-02-18 under 510(k) number K163272. The device is classified under product code PCU. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the AXIOS Stent and Electrocautery Enhanced Delivery System?

AXIOS Stent and Electrocautery Enhanced Delivery System is a medical device that received FDA 510(k) clearance on 2017-02-18. The listed applicant is Boston Scientific Corporation. The 510(k) number is K163272.

When did AXIOS Stent and Electrocautery Enhanced Delivery System receive FDA 510(k) clearance?

AXIOS Stent and Electrocautery Enhanced Delivery System received FDA 510(k) clearance on 2017-02-18, under 510(k) number K163272.

Who is the listed applicant for AXIOS Stent and Electrocautery Enhanced Delivery System?

FDA 510(k) 記錄中將波士頓科學公司列為申請人。這並不單獨確立設備製造商。

What is the FDA product code for AXIOS Stent and Electrocautery Enhanced Delivery System?

The FDA product code for AXIOS Stent and Electrocautery Enhanced Delivery System is PCU.

其他以 Boston Scientific Corporation 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：PCU）

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。

K252648Niti-S SPAXUS支架Taewoong Medical Co., Ltd.K220112AXIOS 支架及電灼強化輸送系統Boston Scientific Corporation K203132AXIOS 支架及電灼輸送強化系統Boston Scientific Corporation K192043AXIOS 支架及電灼輸送強化系統Boston Scientific Corporation K181905AXIOS 支架及輸送系統，AXIOS 支架及電灼輸送強化系統Boston Scientific Corporation

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