FDA 510(k)

EkoSonic內血管設備

K 號：K211080 · 2021-11-19

決定日期2021-11-19

產品代碼QEY

諮詢委員會履歷

決定相當於

器材摘要

EkoSonic 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 2021-11-19 under 510(k) number K211080. 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 EkoSonic Endovascular Device?

EkoSonic Endovascular Device is a medical device that received FDA 510(k) clearance on 2021-11-19. The listed applicant is Boston Scientific. The 510(k) number is K211080.

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

EkoSonic Endovascular Device received FDA 510(k) clearance on 2021-11-19, under 510(k) number K211080.

Who is the listed applicant for EkoSonic 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 EkoSonic Endovascular Device?

The FDA product code for EkoSonic Endovascular Device is QEY.

其他以 Boston Scientific 為申請人之記錄

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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.K220866EKOS+內血管設備Boston Scientific

官方來源

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