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Cardiovascular Systems, Inc.

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

Total Devices14
Categories4
Latest Approval2022-03-01
TypeNumberDevice NameCodeDate
510(k) K220109 DIAMONDBACK 360 Peripheral Orbital Atherectomy System, DIAMONDBACK 360 Peripheral Orbital Atherectomy System, Exchangeable Series, Stealth 360 Peripheral Orbital Atherectomy System MCW 2022-03-01 View
510(k) K212725 ViperCross Support Catheters DQY 2021-09-24 View
510(k) K210586 Diamonback 360 Peripheral Orbital Atherectomy System, Diamondback 360 Stealth Orbital Atherectomy system MCW 2021-09-14 View
510(k) K211240 ViperCross Support Catheters DQY 2021-08-26 View
510(k) K211251 ViperCath XC Peripheral Exchange Catheter DQY 2021-05-26 View
510(k) K210282 WIRION Embolic Protection System NTE 2021-03-03 View
510(k) K203008 DIAMONDBACK 360 Peripheral Orbital Atherectomy System, DIAMONDBACK 360 Peripheral Orbital Atherectomy System, Exchangeable Series, Stealth 360 Peripheral Orbital Atherectomy System MCW 2020-11-19 View
510(k) K200198 WIRION NTE 2020-03-18 View
510(k) K190634 Diamondback 360 Peripheral Orbital Atherectomy System, Stealth 360 Peripheral Orbital Atherectomy System MCW 2019-07-02 View
510(k) K183000 ViperCath XC Peripheral Exchange Catheter DQY 2018-12-29 View
510(k) K182397 Diamondback 360 Peripheral Orbital Atherectomy System Exchangeable Series MCW 2018-12-13 View
510(k) K180416 ViperWire Advance Guide Wire, Stealth 360 Orbital Peripheral Atherectomy Device (PAD), DIAMONDBACK 360 Peripheral Atherectomy System MCW 2018-04-17 View
510(k) K170792 Diamondback 360 Peripheral Orbital Atherectomy System MCW 2017-06-09 View
PMA P130005 CATHETER, CORONARY, ATHERECTOMY MCX 2016-10-26 View
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