FDA 510(k)

海美尼克斯細胞儲存精英自動輸血系統

K 號：K160197 · 2016-05-24

決定日期2016-05-24

產品代碼CAC

諮詢委員會AN

決定相當於

器材摘要

Haemonetics Cell Saver Elite Autotransfusion System is the device name listed in this FDA 510(k) record. The listed applicant is Haemonetics Corporation. It received FDA 510(k) clearance on 2016-05-24 under 510(k) number K160197. The device is classified under product code CAC. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Haemonetics Cell Saver Elite Autotransfusion System?

Haemonetics Cell Saver Elite Autotransfusion System is a medical device that received FDA 510(k) clearance on 2016-05-24. The listed applicant is Haemonetics Corporation. The 510(k) number is K160197.

When did Haemonetics Cell Saver Elite Autotransfusion System receive FDA 510(k) clearance?

Haemonetics Cell Saver Elite Autotransfusion System received FDA 510(k) clearance on 2016-05-24, under 510(k) number K160197.

Who is the listed applicant for Haemonetics Cell Saver Elite Autotransfusion System?

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

What is the FDA product code for Haemonetics Cell Saver Elite Autotransfusion System?

The FDA product code for Haemonetics Cell Saver Elite Autotransfusion System is CAC.

其他以 Haemonetics Corporation 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。

K243858TEG 6s 止血系統經鹽酸處理：K, KH, RT, FF 測試卡匣 K232018Citrated: K, KH, RTH, FFH K221722海美尼克細胞儲存精英/精英+ 自體輸血系統 (CSE-E-US/CSE-EW-US)K183160TEG 6s 止血系統，TEG 6s 經鹽酸處理：K, RT, FF 測試卡匣 K160502TEG 6s 止血系統 K162423海美尼克斯細胞儲存精英/精英+ 自體輸血系統

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相關器械（代碼：CAC）

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。

K241236XTRA 收藏品；XTRA 隔離組Sorin Group Italia S.R.L.K240426Aventus 血栓管理系統Inquis Medical K240584XTRA 自動輸血系統（含 XTRA Bowl 集組）Sorin Group Italia S.R.L.K231782FlowSaver 血液回输系統 (80-101)Inari Medical, Inc.K221483FlowSaver 靈活回血系統Inari Medical, Inc.K221722海美尼克細胞儲存精英/精英+ 自體輸血系統 (CSE-E-US/CSE-EW-US)Haemonetics Corporation

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