FDA 510(k)

EKOS+內血管設備

K 號：K220866 · 2022-04-20

決定日期2022-04-20

產品代碼QEY

諮詢委員會履歷

決定相當於

器材摘要

EKOS+ Endovascular Device is the device name listed in this FDA 510(k) record. The listed applicant is Boston Scientific. It received FDA 510(k) clearance on 2022-04-20 under 510(k) number K220866. The device is classified under product code QEY. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the EKOS+ Endovascular Device?

EKOS+ Endovascular Device is a medical device that received FDA 510(k) clearance on 2022-04-20. The listed applicant is Boston Scientific. The 510(k) number is K220866.

When did EKOS+ Endovascular Device receive FDA 510(k) clearance?

EKOS+ Endovascular Device received FDA 510(k) clearance on 2022-04-20, under 510(k) number K220866.

Who is the listed applicant for EKOS+ Endovascular Device?

FDA 510(k) 記錄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 EKOS+ Endovascular Device?

The FDA product code for EKOS+ Endovascular Device is QEY.

其他以 Boston Scientific 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。

查看所有 30 項裝置 →

相關器械（代碼：QEY）

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。

K260149對比™ 管針 (VS110-9NB)Liquet Medical, Inc.K251318變頻調節輸液針管Argon Medical Devices, Inc.K241851對比™ 管針 (VS110-8B)Liquet Medical, Inc.K231653BASHIR™ .035內血管導管，BASHIR™ S-B .035內血管導管Thrombolex, Inc.K222095BASHIR內血管導管參考編號7201，BASHIR S-B內血管導管，參考編號7101Thrombolex, Inc.K213422EkoSonic內血管設備，EKOS+內血管設備Boston Scientific Corporation

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。