K-number	K242947
Device name	FreedomFlow Orbital Circumferential Atherectomy System
Applicant	Cardio Flow Inc.,
Product code	MCW
Device class	Class II
Decision date	Nov 5, 2024
Decision	Substantially Equivalent
Regulation	870.4875

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Source

View the full FDA submission: accessdata.fda.gov

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FreedomFlow Orbital Circumferential Atherectomy System

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FreedomFlow Orbital Circumferential Atherectomy System