Name: Predicase
Price: 199 USD

K-number	K233483
Device name	FreedomFlow Orbital Circumferential Atherectomy System (H6004/5Fr 3-Sphere Configuration)
Applicant	Cardio Flow Inc.,
Product code	MCW
Device class	Class II
Decision date	Feb 15, 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 (H6004/5Fr 3-Sphere Configuration)

Everything you need for a 510(k) submission. Nothing you don't.