FDA 510(k)

同軸擴張器組（微導入器）

K 號：K172487 · 2017-10-16

決定日期2017-10-16

產品代碼DRE

諮詢委員會履歷

決定Unknown

器材摘要

Coaxial Dilator Set (Micro-Introducer) is the device name listed in this FDA 510(k) record. The listed applicant is Galt Medical Corp.. It received FDA 510(k) clearance on 2017-10-16 under 510(k) number K172487. The device is classified under product code DRE. It was reviewed by the CV advisory panel. FDA Decision: Unknown.

常見問題

What is the Coaxial Dilator Set (Micro-Introducer)?

Coaxial Dilator Set (Micro-Introducer) is a medical device that received FDA 510(k) clearance on 2017-10-16. The listed applicant is Galt Medical Corp.. The 510(k) number is K172487.

When did Coaxial Dilator Set (Micro-Introducer) receive FDA 510(k) clearance?

Coaxial Dilator Set (Micro-Introducer) received FDA 510(k) clearance on 2017-10-16, under 510(k) number K172487.

Who is the listed applicant for Coaxial Dilator Set (Micro-Introducer)?

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

What is the FDA product code for Coaxial Dilator Set (Micro-Introducer)?

The FDA product code for Coaxial Dilator Set (Micro-Introducer) is DRE.

其他以 Galt Medical Corp. 為申請人之記錄

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相關器械（代碼：DRE）

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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