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Cardiovascular Systems, Inc.

FDA 510(k) & PMA Approved Dispositivos — 13 products

Total de dispositivos13
Categorias0
Última decisão da FDA
TipoNúmeroNome do dispositivoCódigoDataAções
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 Ver
510(k) K212725 ViperCross Support CathetersDQY2021-09-24 Ver
510(k) K210586 Diamonback 360 Peripheral Orbital Atherectomy System, Diamondback 360 Stealth Orbital Atherectomy systemMCW2021-09-14 Ver
510(k) K211240 ViperCross Support CathetersDQY2021-08-26 Ver
510(k) K211251 ViperCath XC Peripheral Exchange CatheterDQY2021-05-26 Ver
510(k) K210282 WIRION Embolic Protection SystemNTE2021-03-03 Ver
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 Ver
510(k) K200198 WIRIONNTE2020-03-18 Ver
510(k) K190634 Diamondback 360 Peripheral Orbital Atherectomy System, Stealth 360 Peripheral Orbital Atherectomy SystemMCW2019-07-02 Ver
510(k) K183000 ViperCath XC Peripheral Exchange CatheterDQY2018-12-29 Ver
510(k) K182397 Diamondback 360 Peripheral Orbital Atherectomy System Exchangeable SeriesMCW2018-12-13 Ver
510(k) K180416 ViperWire Advance Guide Wire, Stealth 360 Orbital Peripheral Atherectomy Device (PAD), DIAMONDBACK 360 Peripheral Atherectomy SystemMCW2018-04-17 Ver
510(k) K170792 Diamondback 360 Peripheral Orbital Atherectomy SystemMCW2017-06-09 Ver
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