FDA 510(k)

雙通過扭力

K 號：K162467 · 2017-02-01

決定日期2017-02-01

產品代碼DQY

諮詢委員會履歷

決定相當於

器材摘要

Twin-Pass Torque is the device name listed in this FDA 510(k) record. The listed applicant is Vascular Solutions, Inc.. It received FDA 510(k) clearance on 2017-02-01 under 510(k) number K162467. 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 Twin-Pass Torque?

Twin-Pass Torque is a medical device that received FDA 510(k) clearance on 2017-02-01. The listed applicant is Vascular Solutions, Inc.. The 510(k) number is K162467.

When did Twin-Pass Torque receive FDA 510(k) clearance?

Twin-Pass Torque received FDA 510(k) clearance on 2017-02-01, under 510(k) number K162467.

Who is the listed applicant for Twin-Pass Torque?

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

What is the FDA product code for Twin-Pass Torque?

The FDA product code for Twin-Pass Torque is DQY.

其他以 Vascular Solutions, Inc. 為申請人之記錄

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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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