Name: Predicase
Price: 199 USD

K-number	K210586
Device name	Diamonback 360 Peripheral Orbital Atherectomy System, Diamondback 360 Stealth Orbital Atherectomy system
Applicant	Cardiovascular Systems, Inc.
Product code	MCW
Device class	Class II
Decision date	Sep 14, 2021
Decision	Substantially Equivalent
Regulation	870.4875

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Source

View the full FDA submission: accessdata.fda.gov

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Diamonback 360 Peripheral Orbital Atherectomy System, Diamondback 360 Stealth Orbital Atherectomy system

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