FDA 510(k)

CorPath GRX 系統

K 號：K160121 · 2016-10-27

決定日期2016-10-27

產品代碼DXX

諮詢委員會履歷

決定相當於

器材摘要

CorPath GRX System is the device name listed in this FDA 510(k) record. The listed applicant is Corindus, Inc.. It received FDA 510(k) clearance on 2016-10-27 under 510(k) number K160121. The device is classified under product code DXX. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the CorPath GRX System?

CorPath GRX System is a medical device that received FDA 510(k) clearance on 2016-10-27. The listed applicant is Corindus, Inc.. The 510(k) number is K160121.

When did CorPath GRX System receive FDA 510(k) clearance?

CorPath GRX System received FDA 510(k) clearance on 2016-10-27, under 510(k) number K160121.

Who is the listed applicant for CorPath GRX System?

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

What is the FDA product code for CorPath GRX System?

The FDA product code for CorPath GRX System is DXX.

其他以 Corindus, Inc. 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。

K221464CorPath GRX 系統 K202275CorPath GRX 系統 K180517CorPath GRX 系統 K173806CorPath GRX 系統 K173288CorPath GRX 系統 K152999CorPath 200 系統

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相關器械（代碼：DXX）

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。

K262744GenesisX RMNStereotaxis, Inc.K251792Stereotaxis GenesisX RMN 配置 Navigant™工作站（NWS）Stereotaxis, Inc.K243789LIBERTY內血管機器人系統（LIBERTYOS）Microbot Medical , Ltd.K221464CorPath GRX 系統Corindus, Inc.K202275CorPath GRX 系統Corindus, Inc.K180517CorPath GRX 系統Corindus, Inc.

官方來源

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