K-number	K240776
Device name	Celsio Flexible Cryocatheter System
Applicant	Endocision Technologies, Inc.
Product code	GEH
Device class	Class II
Decision date	Sep 24, 2024
Decision	Substantially Equivalent
Regulation	878.4350

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View the full FDA submission: accessdata.fda.gov

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Celsio Flexible Cryocatheter System

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