K-number	K210655
Device name	Reprocessed Eagle Eye Platinum RX Digital IVUS Catheter
Applicant	Innovative Health, LLC
Product code	OWQ
Device class	Class II
Decision date	May 25, 2022
Decision	Substantially Equivalent
Regulation	870.1200

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Source

View the full FDA submission: accessdata.fda.gov

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Reprocessed Eagle Eye Platinum RX Digital IVUS Catheter

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