FDA 510(k)

FlowSaver 靈活回血系統

K 號：K221483 · 2023-02-17

決定日期2023-02-17

產品代碼CAC

諮詢委員會AN

決定相當於

器材摘要

FlowSaver Blood Return System is the device name listed in this FDA 510(k) record. The listed applicant is Inari Medical, Inc.. It received FDA 510(k) clearance on 2023-02-17 under 510(k) number K221483. 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 FlowSaver Blood Return System?

FlowSaver Blood Return System is a medical device that received FDA 510(k) clearance on 2023-02-17. The listed applicant is Inari Medical, Inc.. The 510(k) number is K221483.

When did FlowSaver Blood Return System receive FDA 510(k) clearance?

FlowSaver Blood Return System received FDA 510(k) clearance on 2023-02-17, under 510(k) number K221483.

Who is the listed applicant for FlowSaver Blood Return System?

FDA 510(k) 記錄將 Inari Medical, Inc. 列為申請人。這並不單獨確立設備製造商。

What is the FDA product code for FlowSaver Blood Return System?

The FDA product code for FlowSaver Blood Return System is CAC.

其他以 Inari Medical, Inc. 為申請人之記錄

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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.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 K201305自動輸血（ATS）胸腔引流管：海洋水封胸腔引流管，Oasis乾式吸引水封胸腔引流管，Express乾式密封胸腔引流管Atrium Medical Corporation

官方來源

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