FDA 510(k)

FibermarX 放射性組織標記劑

K 號：K190155 · 2019-02-27

決定日期2019-02-27

產品代碼IYE

諮詢委員會RA

決定相當於

器材摘要

FibermarX Radiopaque Tissue Marker is the device name listed in this FDA 510(k) record. The listed applicant is Viscus Biologics, LLC. It received FDA 510(k) clearance on 2019-02-27 under 510(k) number K190155. The device is classified under product code IYE. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the FibermarX Radiopaque Tissue Marker?

FibermarX Radiopaque Tissue Marker is a medical device that received FDA 510(k) clearance on 2019-02-27. The listed applicant is Viscus Biologics, LLC. The 510(k) number is K190155.

When did FibermarX Radiopaque Tissue Marker receive FDA 510(k) clearance?

FibermarX Radiopaque Tissue Marker received FDA 510(k) clearance on 2019-02-27, under 510(k) number K190155.

Who is the listed applicant for FibermarX Radiopaque Tissue Marker?

The FDA 510(k) record lists Viscus Biologics, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for FibermarX Radiopaque Tissue Marker?

The FDA product code for FibermarX Radiopaque Tissue Marker is IYE.

其他以 Viscus Biologics, LLC 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。

K170026不透X光組織標記器

相關器械（代碼：IYE）

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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