FDA 510(k)

ICEfx cry오알라벨레이션 시스템 (FPRCH8000-02)

K-번호: K234002 · 2024-03-13

결정일2024-03-13

제품 코드GEH

자문 위원회SU

결정Substantially Equivalent

기기 요약

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.

자주 묻는 질문

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)?

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

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

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

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