FDA 510(k)

FlowSaver 血液回输系統 (80-101)

K 號：K231782 · 2023-07-14

決定日期2023-07-14

產品代碼CAC

諮詢委員會AN

決定相當於

器材摘要

FlowSaver Blood Return System (80-101) 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 2023-07-14 under 510(k) number K231782. 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 (80-101)?

FlowSaver Blood Return System (80-101) is a medical device that received FDA 510(k) clearance on 2023-07-14. The listed applicant is Inari Medical, Inc.. The 510(k) number is K231782.

When did FlowSaver Blood Return System (80-101) receive FDA 510(k) clearance?

FlowSaver Blood Return System (80-101) received FDA 510(k) clearance on 2023-07-14, under 510(k) number K231782.

Who is the listed applicant for FlowSaver Blood Return System (80-101)?

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 (80-101)?

The FDA product code for FlowSaver Blood Return System (80-101) is CAC.

其他以 Inari Medical, 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：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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官方來源

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