FDA 510(k)

Advanta VXT 腹腔內血管移植物，Flixene 腹腔內血管移植物

K 號：K231972 · 2024-03-28

決定日期2024-03-28

產品代碼DSY

諮詢委員會履歷

決定相當於

器材摘要

Advanta VXT Vascular Graft, Flixene Vascular Graft is the device name listed in this FDA 510(k) record. The listed applicant is Atrium Medical Corporation. It received FDA 510(k) clearance on 2024-03-28 under 510(k) number K231972. The device is classified under product code DSY. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Advanta VXT Vascular Graft, Flixene Vascular Graft?

Advanta VXT Vascular Graft, Flixene Vascular Graft is a medical device that received FDA 510(k) clearance on 2024-03-28. The listed applicant is Atrium Medical Corporation. The 510(k) number is K231972.

When did Advanta VXT Vascular Graft, Flixene Vascular Graft receive FDA 510(k) clearance?

Advanta VXT Vascular Graft, Flixene Vascular Graft received FDA 510(k) clearance on 2024-03-28, under 510(k) number K231972.

Who is the listed applicant for Advanta VXT Vascular Graft, Flixene Vascular Graft?

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

What is the FDA product code for Advanta VXT Vascular Graft, Flixene Vascular Graft?

The FDA product code for Advanta VXT Vascular Graft, Flixene Vascular Graft is DSY.

其他以 Atrium Medical Corporation 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：DSY）

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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