FDA 510(k)

海美尼克細胞儲存精英/精英+ 自體輸血系統 (CSE-E-US/CSE-EW-US)

K 號：K221722 · 2022-11-15

決定日期2022-11-15

產品代碼CAC

諮詢委員會AN

決定相當於

器材摘要

Haemonetics Cell Saver Elite/Elite+ Autotransfusion System (CSE-E-US/CSE-EW-US) is the device name listed in this FDA 510(k) record. The listed applicant is Haemonetics Corporation. It received FDA 510(k) clearance on 2022-11-15 under 510(k) number K221722. 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/Elite+ Autotransfusion System (CSE-E-US/CSE-EW-US)?

Haemonetics Cell Saver Elite/Elite+ Autotransfusion System (CSE-E-US/CSE-EW-US) is a medical device that received FDA 510(k) clearance on 2022-11-15. The listed applicant is Haemonetics Corporation. The 510(k) number is K221722.

When did Haemonetics Cell Saver Elite/Elite+ Autotransfusion System (CSE-E-US/CSE-EW-US) receive FDA 510(k) clearance?

Haemonetics Cell Saver Elite/Elite+ Autotransfusion System (CSE-E-US/CSE-EW-US) received FDA 510(k) clearance on 2022-11-15, under 510(k) number K221722.

Who is the listed applicant for Haemonetics Cell Saver Elite/Elite+ Autotransfusion System (CSE-E-US/CSE-EW-US)?

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/Elite+ Autotransfusion System (CSE-E-US/CSE-EW-US)?

The FDA product code for Haemonetics Cell Saver Elite/Elite+ Autotransfusion System (CSE-E-US/CSE-EW-US) 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 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 K160197海美尼克斯細胞儲存精英自動輸血系統

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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。

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