K-number	K230551
Device name	Visual-ICE Cryoablation System
Applicant	Boston Scientific Corporation
Product code	GEH
Device class	Class II
Decision date	Aug 8, 2023
Decision	Substantially Equivalent
Regulation	878.4350

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Source

View the full FDA submission: accessdata.fda.gov

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Visual-ICE Cryoablation System

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