K-number	K222065
Device name	Passeo-35 Xeo Peripheral Dilatation Catheter
Applicant	Biotronik, Inc.
Product code	LIT
Device class	Class II
Decision date	Feb 16, 2023
Decision	Substantially Equivalent
Regulation	870.1250

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View the full FDA submission: accessdata.fda.gov

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Passeo-35 Xeo Peripheral Dilatation Catheter

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