FDA 510(k)

中心橋超低壓導管

K 號：K170403 · 2017-03-07

決定日期2017-03-07

產品代碼DQY

諮詢委員會履歷

決定相當於

器材摘要

CenterCross Ultra LV Catheter is the device name listed in this FDA 510(k) record. The listed applicant is Roxwood Medical, Inc.. It received FDA 510(k) clearance on 2017-03-07 under 510(k) number K170403. 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 CenterCross Ultra LV Catheter?

CenterCross Ultra LV Catheter is a medical device that received FDA 510(k) clearance on 2017-03-07. The listed applicant is Roxwood Medical, Inc.. The 510(k) number is K170403.

When did CenterCross Ultra LV Catheter receive FDA 510(k) clearance?

CenterCross Ultra LV Catheter received FDA 510(k) clearance on 2017-03-07, under 510(k) number K170403.

Who is the listed applicant for CenterCross Ultra LV Catheter?

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

What is the FDA product code for CenterCross Ultra LV Catheter?

The FDA product code for CenterCross Ultra LV Catheter is DQY.

其他以 Roxwood 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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