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U.S. Department of Health and Human Services

510(k) Premarket Notification
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ProductCode: MCW Applicant: Medtronic Vascular, Inc. Decision Date To: 02/02/2023
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hawkone directional atherectomy system Medtronic Vascular, Inc. K161361 10/14/2016
silverhawk peripheral plaque excision system, turbohawk peripheral plaque excision system MEDTRONIC VASCULAR, INC. K170191 06/16/2017
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