FDA 510(k)

Paragonix SherpaPak 心臟運輸系統

K 號：K182735 · 2018-10-19

決定日期2018-10-19

產品代碼MSB

諮詢委員會GU

決定相當於

器材摘要

Paragonix SherpaPak Cardiac Transport System is the device name listed in this FDA 510(k) record. The listed applicant is Paragonix Technologies. It received FDA 510(k) clearance on 2018-10-19 under 510(k) number K182735. 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 Paragonix SherpaPak Cardiac Transport System?

Paragonix SherpaPak Cardiac Transport System is a medical device that received FDA 510(k) clearance on 2018-10-19. The listed applicant is Paragonix Technologies. The 510(k) number is K182735.

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

Paragonix SherpaPak Cardiac Transport System received FDA 510(k) clearance on 2018-10-19, under 510(k) number K182735.

Who is the listed applicant for Paragonix SherpaPak Cardiac Transport System?

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

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

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

其他以 Paragonix Technologies 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。

K234060KIDNEYvault 過濾式腎灌流系統 K223874BAROguard K201048雪巴包兒童肝臟移植系統 K191440Paragonix SherpaPak 腺體運輸系統

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。

K261913X°Port 心臟保護系統Traferox Technologies, Inc.K222535OCS 肺臟捐贈者沖洗組合TransMedics, Inc.K211314OCS 肺部解決方案TransMedics, Inc.K190063Servator C 輔助溶液S.A.L.F. Spa K180194雪巴包心臟輸送系統及雪巴包腎臟輸送系統Paragonix Technologies, Inc.

官方來源

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