K-number	K234002
Device name	ICEfx Cryoablation System (FPRCH8000-02)
Applicant	Boston Scientific
Product code	GEH
Device class	Class II
Decision date	Mar 13, 2024
Decision	Substantially Equivalent
Regulation	878.4350

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View the full FDA submission: accessdata.fda.gov

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ICEfx Cryoablation System (FPRCH8000-02)

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