K-number	K223275
Device name	CELLO II Balloon Guide Catheter
Applicant	Fuji Systems Corporation
Product code	QJP
Device class	Class II
Decision date	Dec 9, 2022
Decision	Substantially Equivalent
Regulation	870.1250

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Source

View the full FDA submission: accessdata.fda.gov

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CELLO II Balloon Guide Catheter

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