FDA 510(k)

speX 支援導管

K 號：K173662 · 2017-12-20

決定日期2017-12-20

產品代碼DQY

諮詢委員會履歷

決定相當於

器材摘要

speX Support Catheter 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 2017-12-20 under 510(k) number K173662. 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 speX Support Catheter?

speX Support Catheter is a medical device that received FDA 510(k) clearance on 2017-12-20. The listed applicant is Reflow Medical, Inc.. The 510(k) number is K173662.

When did speX Support Catheter receive FDA 510(k) clearance?

speX Support Catheter received FDA 510(k) clearance on 2017-12-20, under 510(k) number K173662.

Who is the listed applicant for speX Support Catheter?

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 speX Support Catheter?

The FDA product code for speX Support Catheter 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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