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U.S. Department of Health and Human Services

510(k) Premarket Notification
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1 to 7 of 7 Results
ProductCode: MCW Applicant: Cardiovascular Systems Inc. Decision Date To: 06/01/2024
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diamondback 360 peripheral orbital atherectomy system, diamondback 360 peripheral orbital atherectomy system, exchangeable series, stealth 360 peripheral orbital atherectomy system Cardiovascular Systems Inc. K220109 03/01/2022
diamonback 360 peripheral orbital atherectomy system, diamondback 360 stealth orbital atherectomy system Cardiovascular Systems Inc. K210586 09/14/2021
diamondback 360 peripheral orbital atherectomy system, diamondback 360 peripheral orbital atherectomy system, exchangeable series, stealth 360 peripheral orbital atherectomy system Cardiovascular Systems Inc. K203008 11/19/2020
diamondback 360 peripheral orbital atherectomy system, stealth 360 peripheral orbital atherectomy system Cardiovascular Systems Inc. K190634 07/02/2019
diamondback 360 peripheral orbital atherectomy system exchangeable series Cardiovascular Systems Inc. K182397 12/13/2018
viperwire advance guide wire, stealth 360 orbital peripheral atherectomy device (pad), diamondback 360 peripheral atherectomy system Cardiovascular Systems Inc. K180416 04/17/2018
diamondback 360 peripheral orbital atherectomy system Cardiovascular Systems Inc. K152694 10/21/2015
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