FDA 510(k)

AXIOS 支架及電灼強化輸送系統

K 號：K220112 · 2022-09-07

決定日期2022-09-07

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 2022-09-07 under 510(k) number K220112. 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 2022-09-07. The listed applicant is Boston Scientific Corporation. The 510(k) number is K220112.

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 2022-09-07, under 510(k) number K220112.

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.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 K163272AXIOS 支架及電灼輸送強化系統Boston Scientific Corporation

官方來源

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