FDA 510(k)

S-Wire 絲線導管系統

K 號：K153397 · 2016-08-18

決定日期2016-08-18

產品代碼DQX

諮詢委員會履歷

決定相當於

器材摘要

S-Wire Guidewire System is the device name listed in this FDA 510(k) record. The listed applicant is Concert Medical, LLC. It received FDA 510(k) clearance on 2016-08-18 under 510(k) number K153397. The device is classified under product code DQX. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the S-Wire Guidewire System?

S-Wire Guidewire System is a medical device that received FDA 510(k) clearance on 2016-08-18. The listed applicant is Concert Medical, LLC. The 510(k) number is K153397.

When did S-Wire Guidewire System receive FDA 510(k) clearance?

S-Wire Guidewire System received FDA 510(k) clearance on 2016-08-18, under 510(k) number K153397.

Who is the listed applicant for S-Wire Guidewire System?

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

What is the FDA product code for S-Wire Guidewire System?

The FDA product code for S-Wire Guidewire System is DQX.

其他以 Concert Medical, LLC 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。

K153599康樂醫療無手動針筒（HFS）

相關器械（代碼：DQX）

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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