Cardiovascular Systems, Inc

FDA Filings

This page includes the latest FDA filings for Cardiovascular Systems, Inc. Currently, you will find the latest 25 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

Latest Premarket Notifications

ManufacturerDevice NameDate
Cardiovascular Systems, Inc
WIRION2020-03-18
Cardiovascular Systems Inc.
Diamondback 360 Peripheral Orbital Atherectomy System, Stealth 360 Peripheral Orbital Atherectomy System2019-07-02
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 Inc.
ViperWire Advance Guide Wire, Stealth 360 Orbital Peripheral Atherectomy Device (PAD), DIAMONDBACK 360 Peripheral Atherectomy System2018-04-17
Cardiovascular Systems, Inc.
Diamondback 360 Peripheral Orbital Atherectomy System2017-06-09
Cardiovascular Systems Inc.
Diamondback 360 Peripheral Orbital Atherectomy System2015-10-21
CARDIOVASCULAR SYSTEMS, INC.
Diamondback 360 Peripheral Orbital Atherectomy System2015-04-13
CARDIOVASCULAR SYSTEMS, INC.
DIAMONDBACK 360 PERIPHERAL ORBITAL ATHERECTOMY SYSTEM2014-02-28
CARDIOVASCULAR SYSTEMS INCORPORATED
DIAMONDBACK 360 PERIPHERAL ORBITAL ATHERECTOMY SYSTEM2013-11-22
CARDIOVASCULAR SYSTEMS, INC.
STEALTH 360 ORBITAL PAD SYSTEM2012-10-25
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, INC.
DIAMONDBACK 360 DEGREE ORBITAL ATHERECTOMY SYSTEM2007-08-22

Latest Premarket Applications

PMAManufacturerDevice NameDate
CARDIOVASCULAR SYSTEMS, INC.
Diamondback 360 Coronary Orbital Atherectomy System (OAS)2020-02-24
CARDIOVASCULAR SYSTEMS, INC.
DIAMONDBACK 360 Coronary Orbital Atherectomy System2019-10-09
CARDIOVASCULAR SYSTEMS, INC.
Diamondback 360 Coronary Orbital Atherectomy System2019-09-19
CARDIOVASCULAR SYSTEMS, INC.
Diamondback 360 Coronary Orbital Atherectomy (OAD); Orbital Atherectomy System Pump (OAS Pump)ViperWire Advance C2019-04-10
CARDIOVASCULAR SYSTEMS, INC.
DIAMONDBACK 360 Coronary Orbital Atherectomy System2018-10-04
CARDIOVASCULAR SYSTEMS, INC.
Diamondback 360 Coronary Orbital Atherectomy System2018-06-12
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 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, INC.
DIAMONDBACK 360 CORONARY ORBITAL ATHERECTOMY SYSTEM2015-11-30
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 CORONARY ORIBITAL ATHERECTOMY SYSTEMS (OAS)2015-03-18
CARDIOVASCULAR SYSTEMS, INC.
DIAMONDBACK 360 CORONARY ORBITAL ATHERECTOMY SYSTEM (OAS)2015-02-12
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 CORONARY ORBITAL ATHERECTOMY SYSTEM2013-10-21

Latest De Novo Filings

De NovoManufacturerDevice NameDate

GUDID Registrations

Device GUDID
Device Name
ManufacturerDate
Diamondback Coronary
Cardiovascular Systems, Inc.2020-03-13
Diamondback Coronary
Cardiovascular Systems, Inc.2020-03-13
Extended Length ViperWire Advance
Cardiovascular Systems, Inc.2020-02-10
Diamondback Peripheral
Cardiovascular Systems, Inc.2019-11-21
Diamondback Peripheral
Cardiovascular Systems, Inc.2019-11-21
Diamondback Peripheral
Cardiovascular Systems, Inc.2019-11-21
Diamondback Peripheral
Cardiovascular Systems, Inc.2019-11-21
Diamondback Peripheral
Cardiovascular Systems, Inc.2019-11-21
Diamondback Peripheral
Cardiovascular Systems, Inc.2019-11-21
Diamondback Peripheral
Cardiovascular Systems, Inc.2019-11-21
Diamondback Peripheral
Cardiovascular Systems, Inc.2019-11-21
Diamondback Peripheral
Cardiovascular Systems, Inc.2019-11-21
Diamondback Coronary
Cardiovascular Systems, Inc.2019-10-01
Stealth
Cardiovascular Systems, Inc.2019-09-18
Stealth
Cardiovascular Systems, Inc.2019-09-18
Stealth
Cardiovascular Systems, Inc.2019-09-18
Stealth
Cardiovascular Systems, Inc.2019-09-18
Stealth
Cardiovascular Systems, Inc.2019-09-18
Stealth
Cardiovascular Systems, Inc.2019-09-18
Stealth
Cardiovascular Systems, Inc.2019-09-18
Stealth
Cardiovascular Systems, Inc.2019-09-18
Stealth
Cardiovascular Systems, Inc.2019-09-18

Related Finance Registrations
Cardiovascular Systems Inc of DELAWARE0001180145
Legal Entity Identifier 549300NUBWKJMNMQ3287 [CARDIOVASCULAR SYSTEMS, INC.]
D.U.N.S. 781105734 [CARDIOVASCULAR SYSTEMS INC]

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