FDA 510(k)

coraForce 及 coraFlex 支持導管

K 號：K201811 · 2020-10-26

決定日期2020-10-26

產品代碼DQY

諮詢委員會履歷

決定相當於

器材摘要

coraForce and coraFlex Support Catheters is the device name listed in this FDA 510(k) record. The listed applicant is Reflow Medical, Inc.. It received FDA 510(k) clearance on 2020-10-26 under 510(k) number K201811. The device is classified under product code DQY. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the coraForce and coraFlex Support Catheters?

coraForce and coraFlex Support Catheters is a medical device that received FDA 510(k) clearance on 2020-10-26. The listed applicant is Reflow Medical, Inc.. The 510(k) number is K201811.

When did coraForce and coraFlex Support Catheters receive FDA 510(k) clearance?

coraForce and coraFlex Support Catheters received FDA 510(k) clearance on 2020-10-26, under 510(k) number K201811.

Who is the listed applicant for coraForce and coraFlex Support Catheters?

FDA 510(k) 記錄將 Reflow Medical, Inc. 列為申請人。這並不單獨確立設備製造商。

What is the FDA product code for coraForce and coraFlex Support Catheters?

The FDA product code for coraForce and coraFlex Support Catheters is DQY.

其他以 Reflow Medical, Inc. 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：DQY）

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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官方來源

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