FDA 510(k)

MR 鋸導絲直線型，MR 鋸導絲斜角型

K 號：K173423 · 2017-11-17

決定日期2017-11-17

產品代碼DQX

諮詢委員會履歷

決定相當於

器材摘要

MR Wire Guide Wire Straight, MR Wire Guide Wire Angled is the device name listed in this FDA 510(k) record. The listed applicant is Nano4imaging GmbH. It received FDA 510(k) clearance on 2017-11-17 under 510(k) number K173423. 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 MR Wire Guide Wire Straight, MR Wire Guide Wire Angled?

MR Wire Guide Wire Straight, MR Wire Guide Wire Angled is a medical device that received FDA 510(k) clearance on 2017-11-17. The listed applicant is Nano4imaging GmbH. The 510(k) number is K173423.

When did MR Wire Guide Wire Straight, MR Wire Guide Wire Angled receive FDA 510(k) clearance?

MR Wire Guide Wire Straight, MR Wire Guide Wire Angled received FDA 510(k) clearance on 2017-11-17, under 510(k) number K173423.

Who is the listed applicant for MR Wire Guide Wire Straight, MR Wire Guide Wire Angled?

The FDA 510(k) record lists Nano4imaging GmbH as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MR Wire Guide Wire Straight, MR Wire Guide Wire Angled?

The FDA product code for MR Wire Guide Wire Straight, MR Wire Guide Wire Angled is DQX.

其他以 Nano4imaging GmbH 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。

K253262EmeryGlide™ (EG18008901)K160594MRWire 導引絲

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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官方來源

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