FDA 510(k)

ICEfx Cryoablation System (FPRCH8000-02)

Número K: K234002 · 2024-03-13

Data da decisão2024-03-13

Código do produtoGEH

Comité consultivoSU

DecisãoSubstantially Equivalent

Resumo do dispositivo

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.

Perguntas frequentes

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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