FDA 510(k)

CardioCel 3D

K 號：K170951 · 2017-04-28

決定日期2017-04-28

產品代碼PSQ

諮詢委員會履歷

決定相當於

器材摘要

CardioCel 3D is the device name listed in this FDA 510(k) record. The listed applicant is Admedus Regen Pty, Ltd.. It received FDA 510(k) clearance on 2017-04-28 under 510(k) number K170951. The device is classified under product code PSQ. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the CardioCel 3D?

CardioCel 3D is a medical device that received FDA 510(k) clearance on 2017-04-28. The listed applicant is Admedus Regen Pty, Ltd.. The 510(k) number is K170951.

When did CardioCel 3D receive FDA 510(k) clearance?

CardioCel 3D received FDA 510(k) clearance on 2017-04-28, under 510(k) number K170951.

Who is the listed applicant for CardioCel 3D?

The FDA 510(k) record lists Admedus Regen Pty, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CardioCel 3D?

The FDA product code for CardioCel 3D is PSQ.

其他以 Admedus Regen Pty, Ltd. 為申請人之記錄

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相關器械（代碼：PSQ）

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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