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Cardiovascular Systems, Inc.

FDA 510(k) & PMA Approved Devices — 14 products

Total Devices14
Categories4
Latest FDA decision2026-03-10
TypeNumberDevice NameCodeDateActions
PMA P130005 CATHETER, CORONARY, ATHERECTOMYMCX2026-03-10 View
510(k) K220109 DIAMONDBACK 360 Peripheral Orbital Atherectomy System, DIAMONDBACK 360 Peripheral Orbital Atherectomy System, Exchangeable Series, Stealth 360 Peripheral Orbital Atherectomy SystemMCW2022-03-01 View
510(k) K212725 ViperCross Support CathetersDQY2021-09-24 View
510(k) K210586 Diamonback 360 Peripheral Orbital Atherectomy System, Diamondback 360 Stealth Orbital Atherectomy systemMCW2021-09-14 View
510(k) K211240 ViperCross Support CathetersDQY2021-08-26 View
510(k) K211251 ViperCath XC Peripheral Exchange CatheterDQY2021-05-26 View
510(k) K210282 WIRION Embolic Protection SystemNTE2021-03-03 View
510(k) K203008 DIAMONDBACK 360 Peripheral Orbital Atherectomy System, DIAMONDBACK 360 Peripheral Orbital Atherectomy System, Exchangeable Series, Stealth 360 Peripheral Orbital Atherectomy SystemMCW2020-11-19 View
510(k) K200198 WIRIONNTE2020-03-18 View
510(k) K190634 Diamondback 360 Peripheral Orbital Atherectomy System, Stealth 360 Peripheral Orbital Atherectomy SystemMCW2019-07-02 View
510(k) K183000 ViperCath XC Peripheral Exchange CatheterDQY2018-12-29 View
510(k) K182397 Diamondback 360 Peripheral Orbital Atherectomy System Exchangeable SeriesMCW2018-12-13 View
510(k) K180416 ViperWire Advance Guide Wire, Stealth 360 Orbital Peripheral Atherectomy Device (PAD), DIAMONDBACK 360 Peripheral Atherectomy SystemMCW2018-04-17 View
510(k) K170792 Diamondback 360 Peripheral Orbital Atherectomy SystemMCW2017-06-09 View
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