FDA 510(k)

speX LP 支援導管

K 號：K200094 · 2020-03-18

決定日期2020-03-18

產品代碼DQY

諮詢委員會履歷

決定相當於

器材摘要

speX LP Support Catheter is the device name listed in this FDA 510(k) record. The listed applicant is Reflow Medical. It received FDA 510(k) clearance on 2020-03-18 under 510(k) number K200094. 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 LP Support Catheter?

speX LP Support Catheter is a medical device that received FDA 510(k) clearance on 2020-03-18. The listed applicant is Reflow Medical. The 510(k) number is K200094.

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

speX LP Support Catheter received FDA 510(k) clearance on 2020-03-18, under 510(k) number K200094.

Who is the listed applicant for speX LP Support Catheter?

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

What is the FDA product code for speX LP Support Catheter?

The FDA product code for speX LP Support Catheter is DQY.

其他以 Reflow Medical 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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