FDA 510(k)

血管細

K 號：K162579 · 2016-10-14

決定日期2016-10-14

產品代碼DXZ

諮詢委員會履歷

決定相當於

器材摘要

VascuCel 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 2016-10-14 under 510(k) number K162579. The device is classified under product code DXZ. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the VascuCel?

VascuCel is a medical device that received FDA 510(k) clearance on 2016-10-14. The listed applicant is Admedus Regen Pty, Ltd.. The 510(k) number is K162579.

When did VascuCel receive FDA 510(k) clearance?

VascuCel received FDA 510(k) clearance on 2016-10-14, under 510(k) number K162579.

Who is the listed applicant for VascuCel?

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 VascuCel?

The FDA product code for VascuCel is DXZ.

其他以 Admedus Regen Pty, Ltd. 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。

K200566ADAPT 組織 K170951CardioCel 3D

相關器械（代碼：DXZ）

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。

K240775PeriBeam® 心包膜Tamabio K200955Vascutek Gelseal 补片，Vascutek Gelsoft 补片，Vascutek 薄壁頸動脈補片Vascutek, Ltd.K162506PhotoFix 去細胞牛心包Cryolife, Inc.K152127CorMatrix TykeCormatrix Cardiovascular, Inc.

官方來源

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