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FDA 510(k)

GORE TIPS 集組, GORE TIPS 套管, GORE TIPS 针

K 號：K152913 · 2016-07-21

申請人Creganna Medical Aslo Business AS Cregganna Tactx Medical
決定日期2016-07-21
產品代碼DYB
諮詢委員會履歷
決定相當於

器材摘要

GORE TIPS Set, GORE TIPS Sheath, GORE TIPS Needle is the device name listed in this FDA 510(k) record. The listed applicant is Creganna Medical Aslo Business AS Cregganna Tactx Medical. It received FDA 510(k) clearance on 2016-07-21 under 510(k) number K152913. 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 GORE TIPS Set, GORE TIPS Sheath, GORE TIPS Needle?

GORE TIPS Set, GORE TIPS Sheath, GORE TIPS Needle is a medical device that received FDA 510(k) clearance on 2016-07-21. The listed applicant is Creganna Medical Aslo Business AS Cregganna Tactx Medical. The 510(k) number is K152913.

When did GORE TIPS Set, GORE TIPS Sheath, GORE TIPS Needle receive FDA 510(k) clearance?

GORE TIPS Set, GORE TIPS Sheath, GORE TIPS Needle received FDA 510(k) clearance on 2016-07-21, under 510(k) number K152913.

Who is the listed applicant for GORE TIPS Set, GORE TIPS Sheath, GORE TIPS Needle?

The FDA 510(k) record lists Creganna Medical Aslo Business AS Cregganna Tactx Medical as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for GORE TIPS Set, GORE TIPS Sheath, GORE TIPS Needle?

The FDA product code for GORE TIPS Set, GORE TIPS Sheath, GORE TIPS Needle is DYB.

相關臨床試驗

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其他以 Creganna Medical Aslo Business AS Cregganna Tactx Medical 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。

K162253捕獲交換設備

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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