FDA 510(k)

Nanostim 引入套件

K 號：K160716 · 2016-04-14

決定日期2016-04-14

產品代碼DYB

諮詢委員會履歷

決定相當於

器材摘要

The Nanostim Introducer Kit is the device name listed in this FDA 510(k) record. The listed applicant is St. Jude Medical, Inc.. It received FDA 510(k) clearance on 2016-04-14 under 510(k) number K160716. The device is classified under product code DYB. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the The Nanostim Introducer Kit?

The Nanostim Introducer Kit is a medical device that received FDA 510(k) clearance on 2016-04-14. The listed applicant is St. Jude Medical, Inc.. The 510(k) number is K160716.

When did The Nanostim Introducer Kit receive FDA 510(k) clearance?

The Nanostim Introducer Kit received FDA 510(k) clearance on 2016-04-14, under 510(k) number K160716.

Who is the listed applicant for The Nanostim Introducer Kit?

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

What is the FDA product code for The Nanostim Introducer Kit?

The FDA product code for The Nanostim Introducer Kit is DYB.

其他以 St. Jude Medical, Inc. 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。

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相關器械（代碼：DYB）

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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