FDA 510(k)

ICEfx 冷凍消融系統 (FPRCH8000-02)

K 號：K234002 · 2024-03-13

決定日期2024-03-13

產品代碼GEH

諮詢委員會SU 請提供完整的描述文本，以便我進行翻譯。

決定相當於

器材摘要

ICEfx Cryoablation System (FPRCH8000-02) is the device name listed in this FDA 510(k) record. The listed applicant is Boston Scientific. It received FDA 510(k) clearance on 2024-03-13 under 510(k) number K234002. The device is classified under product code GEH. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the ICEfx Cryoablation System (FPRCH8000-02)?

ICEfx Cryoablation System (FPRCH8000-02) is a medical device that received FDA 510(k) clearance on 2024-03-13. The listed applicant is Boston Scientific. The 510(k) number is K234002.

When did ICEfx Cryoablation System (FPRCH8000-02) receive FDA 510(k) clearance?

ICEfx Cryoablation System (FPRCH8000-02) received FDA 510(k) clearance on 2024-03-13, under 510(k) number K234002.

Who is the listed applicant for ICEfx Cryoablation System (FPRCH8000-02)?

FDA 510(k) 記錄將波士頓科學公司列為申請人。這並不單獨確立設備製造商。

What is the FDA product code for ICEfx Cryoablation System (FPRCH8000-02)?

The FDA product code for ICEfx Cryoablation System (FPRCH8000-02) is GEH.

其他以 Boston Scientific 為申請人之記錄

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相關器械（代碼：GEH）

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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