FDA 510(k)

雪巴包心臟輸送系統及雪巴包腎臟輸送系統

K 號：K180194 · 2018-03-30

決定日期2018-03-30

產品代碼MSB

諮詢委員會GU

決定相當於

器材摘要

SherpaPak Cardiac Transport System and SherpaPak Kidney Transport System is the device name listed in this FDA 510(k) record. The listed applicant is Paragonix Technologies, Inc.. It received FDA 510(k) clearance on 2018-03-30 under 510(k) number K180194. The device is classified under product code MSB. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the SherpaPak Cardiac Transport System and SherpaPak Kidney Transport System?

SherpaPak Cardiac Transport System and SherpaPak Kidney Transport System is a medical device that received FDA 510(k) clearance on 2018-03-30. The listed applicant is Paragonix Technologies, Inc.. The 510(k) number is K180194.

When did SherpaPak Cardiac Transport System and SherpaPak Kidney Transport System receive FDA 510(k) clearance?

SherpaPak Cardiac Transport System and SherpaPak Kidney Transport System received FDA 510(k) clearance on 2018-03-30, under 510(k) number K180194.

Who is the listed applicant for SherpaPak Cardiac Transport System and SherpaPak Kidney Transport System?

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

What is the FDA product code for SherpaPak Cardiac Transport System and SherpaPak Kidney Transport System?

The FDA product code for SherpaPak Cardiac Transport System and SherpaPak Kidney Transport System is MSB.

其他以 Paragonix Technologies, 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。

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相關器械（代碼：MSB）

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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