Atlas FDA

Cardiovascular Systems, Inc.

50 FDA 510(k) clearances · PMA applicant

Sort:Newest firstOldest first

◉ Watch Cardiovascular Systems, Inc.

RecordFirmDate
Diamondback 360 Coronary Orbital Atherectomy System; Diamondback 360 Precision Coronary Orbital Atherectomy System (P130005/S047)Cardiovascular Systems, Inc.2025-06-03
DIAMONDBACK 360® and Diamondback 360 Precision™ Coronary Orbital Atherectomy System (OAS) (P130005/S045)Cardiovascular Systems, Inc.2025-04-24
Diamondback 360™ Coronary Orbital Atherectomy System, Diamondback 360 Precision™ Coronary Orbital Atherectomy System (P130005/S046)Cardiovascular Systems, Inc.2025-04-14
Diamondback 360 Orbital Atherectomy and Diamondback 360 Precision Coronary Orbital Atherectomy System (OAS) (P130005/S044)Cardiovascular Systems, Inc.2024-12-12
DIAMONDBACK 360 Coronary Orbital Atherectomy System (OAS), DIAMONDBACK 360 Precision Coronary Orbital Atherectomy System (P130005/S043)Cardiovascular Systems, Inc.2024-10-28
DIAMONDBACK 360 Precision Coronary Orbital Atherectomy System (OAS) (P130005/S042)Cardiovascular Systems, Inc.2024-05-02
DIAMONDBACK 360 Precision Coronary Orbital Atherectomy System (OAS) (P130005/S040)Cardiovascular Systems, Inc.2023-12-14
DIAMONDBACK 360® Coronary Orbital Atherectomy System (OAS) (P130005/S041)Cardiovascular Systems, Inc.2023-11-27
DIAMONDBACK 360 Coronary Orbital Atherectomy System (OAS), DIAMONDBACK 360 Precision Coronary Orbital Atherectomy System (P130005/S039)Cardiovascular Systems, Inc.2023-10-24
DIAMONDBACK 360 Coronary Orbital Atherectomy System, DIAMONDBACK 360 Precision Coronary Orbital Atherectomy System (P130005/S038)Cardiovascular Systems, Inc.2023-09-07
DIAMONDBACK 360® and DIAMONDBACK 360 PRECISION ™ Coronary Orbital Atherectomy System (OAS) (P130005/S037)Cardiovascular Systems, Inc.2023-07-28
Diamondback 360 Precision Coronary Orbital Atherectomy System (P130005/S036)Cardiovascular Systems, Inc.2023-06-01
DIAMONDBACK 360 CORONARY ORBITAL ATHERECTOMY SYSTEM (P130005/S034)Cardiovascular Systems, Inc.2022-04-06
Diamondback 360 Coronary Orbital Atherectomy System (P130005/S035)Cardiovascular Systems, Inc.2022-03-11
DIAMONDBACK 360 Coronary Orbital Atherectomy System (OAS) (P130005/S033)Cardiovascular Systems, Inc.2021-04-23
DIAMONDBACK 360 Coronary Orbital Atherectomy System (OAS) (P130005/S032)Cardiovascular Systems, Inc.2021-01-14
DIAMONDBACK 360 Coronary Orbital Atherectomy System (OAS) (P130005/S031)Cardiovascular Systems, Inc.2020-12-10
Diamondback 360 Coronary Orbital Atherectomy System (OAS) (P130005/S030)Cardiovascular Systems, Inc.2020-07-15
DIAMONDBACK 360 Coronary Orbital Atherectomy System (OAS) (P130005/S029)Cardiovascular Systems, Inc.2020-06-18
Diamondback 360 Coronary Orbital Atherectomy System (OAS) (P130005/S028)Cardiovascular Systems, Inc.2020-02-24
DIAMONDBACK 360 Coronary Orbital Atherectomy System (P130005/S027)Cardiovascular Systems, Inc.2019-10-09
Diamondback 360 Coronary Orbital Atherectomy System (P130005/S021)Cardiovascular Systems, Inc.2019-09-19
Diamondback 360 Coronary Orbital Atherectomy Device (OAD); Orbital Atherectomy System Pump (OAS Pump)ViperWire Advance C (P130005/S025)Cardiovascular Systems, Inc.2019-04-10
DIAMONDBACK 360 Coronary Orbital Atherectomy System (P130005/S022)Cardiovascular Systems, Inc.2018-10-04
Diamondback 360 Coronary Orbital Atherectomy System (P130005/S024)Cardiovascular Systems, Inc.2018-06-12
Diamond Back 360 Coronary Orbital Atherectomy System (P130005/S019)Cardiovascular Systems, Inc.2018-02-09
Diamondback 360 Coronary Orbital Atherectomy System (OAS) Micro Crown Orbital Atherectomy Device (OAD) (P130005/S020)Cardiovascular Systems, Inc.2017-11-17
DIAMONDBACK 360 Coronary Orbital Atherectomy System (OAS) Classic Crown (P130005/S018)Cardiovascular Systems, Inc.2017-10-20
DIAMONDBACK 360 Orbital Atherectomy System (P130005/S017)Cardiovascular Systems, Inc.2017-08-02
Diamondback 360 Coronary Orbital Atherectomy Device (OAD) (P130005/S016)Cardiovascular Systems, Inc.2017-05-03
DIAMONDBACK 360 CORONARY ORBITAL ATHERECTOMY DEVICE (OAD), ORBITAL ATHERECTOMY SYSTEM PUMP (OAS PUMP), VIPERWIRE ADVANCE (P130005/S014)Cardiovascular Systems, Inc.2017-03-19
DIAMONDBACK 360 CORONARY ORBITAL ATHERECTOMY SYSTEM (P130005/S015)Cardiovascular Systems, Inc.2017-02-23
DIAMONDBACK 360 CORONARY ORBITAL ATHERECTOMY SYSTEM (P130005/S012)Cardiovascular Systems, Inc.2016-10-26
DIAMONDBACK 360 CORONARY ORBITAL ATHERECTOMY SYSTEM (P130005/S013)Cardiovascular Systems, Inc.2016-06-07
DIAMONDBACK 360 CORONARY ORBITAL ATHERECTOMY SYSTEM (P130005/S011)Cardiovascular Systems, Inc.2016-03-16
DIAMONDBACK 360 CORONARY ORBITAL ATHERECTOMY DEVICE (OAD), ORBITAL ATHERECTOMY SYSTEM PUMP (OAS PUMP), VIPERWIRE ADVANCE (P130005/S010)Cardiovascular Systems, Inc.2016-01-21
DIAMONDBACK 360 CORONARY ORBITAL ATHERECTOMY SYSTEM (P130005/S007)Cardiovascular Systems, Inc.2015-11-30
DIAMONDBACK 360 CORONARY ORBITAL ATHERECTOMY SYSTEM (OAS) (P130005/S005)Cardiovascular Systems, Inc.2015-07-07
DIAMONDBACK 360 CORONARY ORIBITAL ATHERECTOMY SYSTEM (OAS) (P130005/S008)Cardiovascular Systems, Inc.2015-06-25
DIAMONDBACK 360 CORONARY ORBITAL ATHERECTOMY SYSTEM (OAS) (P130005/S009)Cardiovascular Systems, Inc.2015-06-25
DIAMONDBACK 360 CORONARY ORBITAL ATHERECTOMY SYSTEM (OAS) (P130005/S004)Cardiovascular Systems, Inc.2015-05-14
DIAMONDBACK 360 CORONARY ORIBITAL ATHERECTOMY SYSTEMS (OAS) (P130005/S006)Cardiovascular Systems, Inc.2015-03-18
DIAMONDBACK 360 CORONARY ORBITAL ATHERECTOMY SYSTEM (OAS) (P130005/S002)Cardiovascular Systems, Inc.2015-02-12
DIAMONDBACK 360 CONONARY ORBITAL ATHERECTOMY SYSTEM (P130005/S001)Cardiovascular Systems, Inc.2014-10-29
DIAMONDBACK 360 CORONARY ORBITAL ATHERECTOMY SYSTEM (P130005/S003)Cardiovascular Systems, Inc.2014-09-26
DIAMONDBACK 360 CORONARY ORBITAL ATHERECTOMY SYSTEM (P130005)Cardiovascular Systems, Inc.2013-10-21

Track Cardiovascular Systems, Inc. automatically

Every clearance here is in the API, with alerts when new ones post.