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U.S. Department of Health and Human Services

510(k) Premarket Notification
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ProductCode: MCW Applicant: CARDIOVASCULAR SYSTEMS INCORPORATED Decision Date To: 05/02/2024
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diamondback 360 peripheral orbital atherectomy system CARDIOVASCULAR SYSTEMS INCORPORATED K133399 11/22/2013
orbital atherectomy system for treatment of a-v shunt stenosis CARDIOVASCULAR SYSTEMS INCORPORATED K041630 01/31/2005
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