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Cardiovascular Systems, Inc.

FDA 510(k) & PMA Approved Devices — 23 products

Total Devices23
Categories0
Latest FDA decision
TypeNumberDevice NameCodeDateActions
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
510(k) K122987 STEALTH 360 ORBITAL PAD SYSTEMMCW2012-10-25 View
510(k) K111388 DIAMONDBACK 360* ORBITAL ATHERECTOMY SYSTEM, STEALTH 360* ORBITAL PAD SYSTEMMCW2011-07-26 View
510(k) K110389 STEALTH 360 ORBITAL PAD SYSTEMMCW2011-03-11 View
510(k) K090521 DIAMONDBACK 360 DBXMCW2009-03-20 View
510(k) K083139 VIPERSPHERE PTA BALLOON CATHETERDQY2008-11-25 View
510(k) K082981 DIAMONDBACK 360 DEGREE ORBITAL ATHERECTOMY SYSTEM WITH VIPERSLIDE LUBRICANTMCW2008-10-31 View
510(k) K072748 MODIFICATION TO: DIAMONDBACK 360 ORBITAL ATHERECTOMY SYSTEMMCW2007-11-09 View
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