K-number	K230584
Device name	Vein360 Reprocessed Visions PV.035 Digital IVUS Catheter
Applicant	Vein 360, LLC
Product code	OWQ
Device class	Class II
Decision date	Jun 6, 2023
Decision	Substantially Equivalent
Regulation	870.1200

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Source

View the full FDA submission: accessdata.fda.gov

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Vein360 Reprocessed Visions PV.035 Digital IVUS Catheter

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