FDA 510(k)

VSI StraitSet 微導管套件

K 號：K161336 · 2016-08-11

決定日期2016-08-11

產品代碼DRE

諮詢委員會履歷

決定相當於

器材摘要

VSI StraitSet micro-introducer kit 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 2016-08-11 under 510(k) number K161336. The device is classified under product code DRE. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the VSI StraitSet micro-introducer kit?

VSI StraitSet micro-introducer kit is a medical device that received FDA 510(k) clearance on 2016-08-11. The listed applicant is Vascular Solutions, Inc.. The 510(k) number is K161336.

When did VSI StraitSet micro-introducer kit receive FDA 510(k) clearance?

VSI StraitSet micro-introducer kit received FDA 510(k) clearance on 2016-08-11, under 510(k) number K161336.

Who is the listed applicant for VSI StraitSet micro-introducer kit?

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 VSI StraitSet micro-introducer kit?

The FDA product code for VSI StraitSet micro-introducer kit is DRE.

其他以 Vascular Solutions, Inc. 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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