FDA 510(k)

transGlideXT 可擴展導管

K 號：K181817 · 2019-03-26

決定日期2019-03-26

產品代碼DYB

諮詢委員會履歷

決定相當於

器材摘要

transGlideXT Expandable Introducer is the device name listed in this FDA 510(k) record. The listed applicant is Transaortic Medical, Inc.. It received FDA 510(k) clearance on 2019-03-26 under 510(k) number K181817. 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 transGlideXT Expandable Introducer?

transGlideXT Expandable Introducer is a medical device that received FDA 510(k) clearance on 2019-03-26. The listed applicant is Transaortic Medical, Inc.. The 510(k) number is K181817.

When did transGlideXT Expandable Introducer receive FDA 510(k) clearance?

transGlideXT Expandable Introducer received FDA 510(k) clearance on 2019-03-26, under 510(k) number K181817.

Who is the listed applicant for transGlideXT Expandable Introducer?

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

What is the FDA product code for transGlideXT Expandable Introducer?

The FDA product code for transGlideXT Expandable Introducer is DYB.

其他以 Transaortic Medical, Inc. 為申請人之記錄

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K152194transGlide 可擴展導管

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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