FDA 510(k)

XenoSure Dura 生物貼片

K 號：K183513 · 2019-06-13

決定日期2019-06-13

產品代碼GXQ

諮詢委員會NE (請提供完整的英文描述，以便進行翻譯。)

決定相當於

器材摘要

XenoSure Dura Biologic Patch is the device name listed in this FDA 510(k) record. The listed applicant is LeMaitre Vascular, Inc.. It received FDA 510(k) clearance on 2019-06-13 under 510(k) number K183513. The device is classified under product code GXQ. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the XenoSure Dura Biologic Patch?

XenoSure Dura Biologic Patch is a medical device that received FDA 510(k) clearance on 2019-06-13. The listed applicant is LeMaitre Vascular, Inc.. The 510(k) number is K183513.

When did XenoSure Dura Biologic Patch receive FDA 510(k) clearance?

XenoSure Dura Biologic Patch received FDA 510(k) clearance on 2019-06-13, under 510(k) number K183513.

Who is the listed applicant for XenoSure Dura Biologic Patch?

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

What is the FDA product code for XenoSure Dura Biologic Patch?

The FDA product code for XenoSure Dura Biologic Patch is GXQ.

其他以 LeMaitre Vascular, Inc. 為申請人之記錄

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相關器械（代碼：GXQ）

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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