FDA 510(k)

CoroFlow 心血管系統

K 號：K201881 · 2020-11-13

決定日期2020-11-13

產品代碼DQK

諮詢委員會履歷

決定相當於

器材摘要

CoroFlow Cardiovascular System is the device name listed in this FDA 510(k) record. The listed applicant is Coroventis Research AB. It received FDA 510(k) clearance on 2020-11-13 under 510(k) number K201881. The device is classified under product code DQK. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the CoroFlow Cardiovascular System?

CoroFlow Cardiovascular System is a medical device that received FDA 510(k) clearance on 2020-11-13. The listed applicant is Coroventis Research AB. The 510(k) number is K201881.

When did CoroFlow Cardiovascular System receive FDA 510(k) clearance?

CoroFlow Cardiovascular System received FDA 510(k) clearance on 2020-11-13, under 510(k) number K201881.

Who is the listed applicant for CoroFlow Cardiovascular System?

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

What is the FDA product code for CoroFlow Cardiovascular System?

The FDA product code for CoroFlow Cardiovascular System is DQK.

其他以 Coroventis Research AB 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。

K252238CoroFlow 心血管系統

相關器械（代碼：DQK）

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。

K261729EnSite™ X EP 系統Abbott Medical K262005Affera 整合地圖系統Medtronic, Inc.K253692AVVIGO™+ 多模態導引系統Boston Scientific K253576CorVista System® 內建 PCWP 附加功能Analytics For Life, Inc.K262006EnSite™ X EP 系統Abbott Medical K252978ScioCardio 心電圖分析平台Synergen Technology Labs, LLC

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。