FDA 510(k)

VirtuoSaph Plus內視鏡血管採集系統

K 號：K160206 · 2016-04-21

申請人Terumo Cardiovascular Systems Corporation

決定日期2016-04-21

產品代碼GEI

諮詢委員會SU 請提供完整的描述文本，以便我進行翻譯。

決定相當於

器材摘要

VirtuoSaph Plus Endoscopic Vessel Harvesting System is the device name listed in this FDA 510(k) record. The listed applicant is Terumo Cardiovascular Systems Corporation. It received FDA 510(k) clearance on 2016-04-21 under 510(k) number K160206. The device is classified under product code GEI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the VirtuoSaph Plus Endoscopic Vessel Harvesting System?

VirtuoSaph Plus Endoscopic Vessel Harvesting System is a medical device that received FDA 510(k) clearance on 2016-04-21. The listed applicant is Terumo Cardiovascular Systems Corporation. The 510(k) number is K160206.

When did VirtuoSaph Plus Endoscopic Vessel Harvesting System receive FDA 510(k) clearance?

VirtuoSaph Plus Endoscopic Vessel Harvesting System received FDA 510(k) clearance on 2016-04-21, under 510(k) number K160206.

Who is the listed applicant for VirtuoSaph Plus Endoscopic Vessel Harvesting System?

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

What is the FDA product code for VirtuoSaph Plus Endoscopic Vessel Harvesting System?

The FDA product code for VirtuoSaph Plus Endoscopic Vessel Harvesting System is GEI.

其他以 Terumo Cardiovascular Systems Corporation 為申請人之記錄

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相關器械（代碼：GEI）

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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