Name: Predicase
Price: 199 USD

K-number	K213303
Device name	Makoto Intravascular Imaging System, TVC-MC10/TVC-MC10i, Dualpro IVUS + NIRS Imaging Catheter ,TVC-C195-42, Peripheral 014 Imaging Catheter, TVC-E195-42
Applicant	Infraredx, Inc.
Product code	IYO
Device class	Class II
Decision date	Dec 7, 2021
Decision	Substantially Equivalent
Regulation	892.1560

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Source

View the full FDA submission: accessdata.fda.gov

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Makoto Intravascular Imaging System, TVC-MC10/TVC-MC10i, Dualpro IVUS + NIRS Imaging Catheter ,TVC-C195-42, Peripheral 014 Imaging Catheter, TVC-E195-42

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