Cardiovascular Systems Inc

FDA Filings

This page includes the latest FDA filings for Cardiovascular Systems Inc. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

USANASDAQCSIIDUNS 024954518
FDA Registration(s)
Registration Number3008814558
FEI Number3008814558
NameCARDIOVASCULAR SYSTEMS INCORPORATED
Owner & OperatorCARDIOVASCULAR SYSTEMS INCORPORATED
Contact Address1225 Old Hwy 8 NW --
Saint Paul MN 55112 US
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address14740 Kirby Dr
Houston, TX 77047 US
Establishment Type
  • Manufacture Medical Device
  • Complaint File Establishment per 21 CFR 820.198



Registration Number3004742232
FEI Number3004742232
NameCardiovascular Systems Incorporated
Owner & OperatorCARDIOVASCULAR SYSTEMS INCORPORATED
Contact Address1225 Old Hwy 8 NW --
Saint Paul MN 55112 US
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address1225 Old Highway 8 NW
Saint Paul, MN 55112 US
Establishment Type
  • Develop Specifications But Do Not Manufacture At This Facility
  • Manufacture Medical Device



FDA Filings

Device
Company
DeviceDate
CARDIOVASCULAR SYSTEMS, INC.
DIAMONDBACK 360 Coronary Orbital Atherectomy System (OAS)2020-06-18
Cardiovascular Systems Incorporated
WIRION2020-04-03
Cardiovascular Systems, Inc
WIRION2020-03-18
Cardiovascular Systems, Inc.
Diamondback Coronary 7-10060-022020-03-13
Cardiovascular Systems, Inc.
Diamondback Coronary 7-10060-012020-03-13
CARDIOVASCULAR SYSTEMS, INC.
Diamondback 360 Coronary Orbital Atherectomy System (OAS)2020-02-24
Cardiovascular Systems, Inc.
Extended Length ViperWire Advance 2020-02-10
Cardiovascular Systems, Inc.
Diamondback Peripheral 7-10057-092019-11-21
Cardiovascular Systems, Inc.
Diamondback Peripheral 7-10057-082019-11-21
Cardiovascular Systems, Inc.
Diamondback Peripheral 7-10057-072019-11-21
Cardiovascular Systems, Inc.
Diamondback Peripheral 7-10057-062019-11-21
Cardiovascular Systems, Inc.
Diamondback Peripheral 7-10057-052019-11-21
Cardiovascular Systems, Inc.
Diamondback Peripheral 7-10057-042019-11-21
Cardiovascular Systems, Inc.
Diamondback Peripheral 7-10057-032019-11-21
Cardiovascular Systems, Inc.
Diamondback Peripheral 7-10057-022019-11-21
Cardiovascular Systems, Inc.
Diamondback Peripheral 7-10057-012019-11-21
Cardiovascular Systems Incorporated
Stealth OAS2019-10-30
Cardiovascular Systems Incorporated
Diamondback OAS2019-10-30
CARDIOVASCULAR SYSTEMS INCORPORATED
Stealth OAS2019-10-30
CARDIOVASCULAR SYSTEMS INCORPORATED
Diamondback OAS2019-10-30
Cardiovascular Systems Incorporated
Diamondback 360 Peripheral Orbital Atherectomy System Exchangeable Series2019-10-30
CARDIOVASCULAR SYSTEMS INCORPORATED
Diamondback 360 Peripheral Orbital Atherectomy System Exchangeable Series2019-10-30
CARDIOVASCULAR SYSTEMS, INC.
DIAMONDBACK 360 Coronary Orbital Atherectomy System2019-10-09
Cardiovascular Systems, Inc.
Diamondback Coronary 7-10038-012019-10-01
CARDIOVASCULAR SYSTEMS, INC.
Diamondback 360 Coronary Orbital Atherectomy System2019-09-19
Cardiovascular Systems, Inc.
Stealth 7-10059-092019-09-18
Cardiovascular Systems, Inc.
Stealth 7-10059-082019-09-18
Cardiovascular Systems, Inc.
Stealth 7-10059-072019-09-18
Cardiovascular Systems, Inc.
Stealth 7-10059-062019-09-18
Cardiovascular Systems, Inc.
Stealth 7-10059-052019-09-18
Cardiovascular Systems, Inc.
Stealth 7-10059-042019-09-18
Cardiovascular Systems, Inc.
Stealth 7-10059-032019-09-18
Cardiovascular Systems, Inc.
Stealth 7-10059-022019-09-18
Cardiovascular Systems, Inc.
Stealth 7-10059-012019-09-18
Cardiovascular Systems Inc.
Diamondback 360 Peripheral Orbital Atherectomy System, Stealth 360 Peripheral Orbital Atherectomy System2019-07-02
CARDIOVASCULAR SYSTEMS, INC.
Diamondback 360 Coronary Orbital Atherectomy (OAD); Orbital Atherectomy System Pump (OAS Pump)ViperWire Advance C2019-04-10
CARDIOVASCULAR SYSTEMS INCORPORATED
ViperCath XC Peripheral Exchange Catheter2019-01-03
Cardiovascular Systems, Inc.
ViperCath XC Peripheral Exchange Catheter2018-12-29
Cardiovascular Systems Inc.
Diamondback 360 Peripheral Orbital Atherectomy System Exchangeable Series2018-12-13
Cardiovascular Systems Incorporated
Diamondback2018-12-12
CARDIOVASCULAR SYSTEMS INCORPORATED
Diamondback2018-12-12
CARDIOVASCULAR SYSTEMS, INC.
DIAMONDBACK 360 Coronary Orbital Atherectomy System2018-10-04
Cardiovascular Systems Incorporated
Viperwire Advance with Flextip2018-06-15
CARDIOVASCULAR SYSTEMS INCORPORATED
Viperwire Advance with Flextip2018-06-15
CARDIOVASCULAR SYSTEMS, INC.
Diamondback 360 Coronary Orbital Atherectomy System2018-06-12
Cardiovascular Systems Inc.
ViperWire Advance Guide Wire, Stealth 360 Orbital Peripheral Atherectomy Device (PAD), DIAMONDBACK 360 Peripheral Atherectomy System2018-04-17
CARDIOVASCULAR SYSTEMS, INC.
Diamond Back 360 Coronary Orbital Atherectomy System2018-02-09
CARDIOVASCULAR SYSTEMS, INC.
Diamondback 360 Coronary Orbital Atherectomy System (OAS) Micro Crown Orbital Atherectomy (OAD)2017-11-17
CARDIOVASCULAR SYSTEMS, INC.
DIAMONDBACK 360 Coronary Orbital Atherectomy System (OAS) Classic Crown2017-10-20
CARDIOVASCULAR SYSTEMS, INC.
DIAMONDBACK 360 Orbital Atherectomy System2017-08-02
Cardiovascular Systems, Inc.
Diamondback 360 Peripheral Orbital Atherectomy System2017-06-09
CARDIOVASCULAR SYSTEMS, INC.
Diamondback 360 Coronary Orbital Atherectomy (OAD)2017-05-03
CARDIOVASCULAR SYSTEMS, INC.
DIAMONDBACK 360 CORONARY ORBITAL ATHERECTOMY DEVICE (OAD), ORBITAL ATHERECTOMY SYSTEM PUMP (OAS PUMP), VIPERWIRE ADVANCE2017-03-19
CARDIOVASCULAR SYSTEMS, INC.
DIAMONDBACK 360 CORONARY ORBITAL ATHERECTOMY SYSTEM2017-02-23
CARDIOVASCULAR SYSTEMS, INC.
DIAMONDBACK 360 CORONARY ORBITAL ATHERECTOMY SYSTEM2016-10-26
CARDIOVASCULAR SYSTEMS, INC.
DIAMONDBACK 360 CORONARY ORBITAL ATHERECTOMY SYSTEM2016-06-07
CARDIOVASCULAR SYSTEMS, INC.
DIAMONDBACK 360 CORONARY ORBITAL ATHERECTOMY SYSTEM2016-03-16
CARDIOVASCULAR SYSTEMS, INC.
DIAMONDBACK 360 CORONARY ORBITAL ATHERECTOMY DEVICE (OAD), ORBITAL ATHERECTOMY SYSTEM PUMP (OAS PUMP), VIPERWIRE ADVANCE2016-01-21
Cardiovascular Systems Incorporated
DIAMONDBACK 360 Peripheral Orbital Atherectomy System2015-12-04
CARDIOVASCULAR SYSTEMS INCORPORATED
DIAMONDBACK 360 Peripheral Orbital Atherectomy System2015-12-04
Cardiovascular Systems Incorporated
VIPERWIRE ADVANCE with FLEXTIP Peripheral Atherectomy Guidewire2015-12-04
CARDIOVASCULAR SYSTEMS INCORPORATED
VIPERWIRE ADVANCE with FLEXTIP Peripheral Atherectomy Guidewire2015-12-04
Cardiovascular Systems Incorporated
DIAMONDBACK 360 Peripheral Orbital Atherectomy System2015-12-04
CARDIOVASCULAR SYSTEMS INCORPORATED
DIAMONDBACK 360 Peripheral Orbital Atherectomy System2015-12-04
CARDIOVASCULAR SYSTEMS, INC.
DIAMONDBACK 360 CORONARY ORBITAL ATHERECTOMY SYSTEM2015-11-30
Cardiovascular Systems Inc.
Diamondback 360 Peripheral Orbital Atherectomy System2015-10-21
CARDIOVASCULAR SYSTEMS, INC.
DIAMONDBACK 360 CORONARY ORBITAL ATHERECTOMY SYSTEM (OAS)2015-07-07
CARDIOVASCULAR SYSTEMS, INC.
DIAMONDBACK 360 CORONARY ORBITAL ATHERECTOMY SYSTEM (OAS)2015-06-25
CARDIOVASCULAR SYSTEMS, INC.
DIAMONDBACK 360 CORONARY ORIBITAL ATHERECTOMY SYSTEM (OAS)2015-06-25
CARDIOVASCULAR SYSTEMS, INC.
DIAMONDBACK 360 CORONARY ORBITAL ATHERECTOMY SYSTEM (OAS)2015-05-14
CARDIOVASCULAR SYSTEMS, INC.
Diamondback 360 Peripheral Orbital Atherectomy System2015-04-13
CARDIOVASCULAR SYSTEMS, INC.
DIAMONDBACK 360 CORONARY ORIBITAL ATHERECTOMY SYSTEMS (OAS)2015-03-18
CARDIOVASCULAR SYSTEMS, INC.
DIAMONDBACK 360 CORONARY ORBITAL ATHERECTOMY SYSTEM (OAS)2015-02-12
Cardiovascular Systems Incorporated
Diamondback Peripheral Micro2014-10-31
CARDIOVASCULAR SYSTEMS INCORPORATED
Diamondback Peripheral Micro2014-10-31
Cardiovascular Systems Incorporated
Diamondback Peripheral Micro2014-10-31
CARDIOVASCULAR SYSTEMS INCORPORATED
Diamondback Peripheral Micro2014-10-31
CARDIOVASCULAR SYSTEMS, INC.
DIAMONDBACK 360 CONONARY ORBITAL ATHERECTOMY SYSTEM2014-10-29
CARDIOVASCULAR SYSTEMS, INC.
DIAMONDBACK 360 CORONARY ORBITAL ATHERECTOMY SYSTEM2014-09-26
CARDIOVASCULAR SYSTEMS, INC.
DIAMONDBACK 360 PERIPHERAL ORBITAL ATHERECTOMY SYSTEM2014-02-28
CARDIOVASCULAR SYSTEMS INCORPORATED
DIAMONDBACK 360 PERIPHERAL ORBITAL ATHERECTOMY SYSTEM2013-11-22
Cardiovascular Systems Incorporated
DIAMONDBACK 360 Coronary Orbital Atherectomy System2013-10-28
CARDIOVASCULAR SYSTEMS INCORPORATED
DIAMONDBACK 360 Coronary Orbital Atherectomy System2013-10-28
CARDIOVASCULAR SYSTEMS, INC.
DIAMONDBACK 360 CORONARY ORBITAL ATHERECTOMY SYSTEM2013-10-21
CARDIOVASCULAR SYSTEMS, INC.
STEALTH 360 ORBITAL PAD SYSTEM2012-10-25
Cardiovascular Systems Incorporated
ViperSlide Lubricant2012-01-16
Cardiovascular Systems Incorporated
Stealth 360 PAD System2011-11-29
CARDIOVASCULAR SYSTEMS INCORPORATED
Stealth 360 PAD System2011-11-29
CARDIOVASCULAR SYSTEMS, INC.
DIAMONDBACK 360* ORBITAL ATHERECTOMY SYSTEM, STEALTH 360* ORBITAL PAD SYSTEM2011-07-26
CARDIOVASCULAR SYSTEMS, INC.
STEALTH 360 ORBITAL PAD SYSTEM2011-03-11
Cardiovascular Systems Incorporated
ViperTrack2008-09-19
CARDIOVASCULAR SYSTEMS, INC.
DIAMONDBACK 360 DEGREE ORBITAL ATHERECTOMY SYSTEM2007-10-25
CARDIOVASCULAR SYSTEMS, INC.
DIAMONDBACK 360 DEGREE ORBITAL ATHERECTOMY SYSTEM2007-08-22
CARDIOVASCULAR SYSTEMS INCORPORATED
ORBITAL ATHERECTOMY SYSTEM FOR TREATMENT OF A-V SHUNT STENOSIS2005-01-31

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