FDA.reportPublic FDA data

Cardiovascular Systems Incorporated

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30047422323004742232Cardiovascular Systems Incorporated1N2026-01-011225 Old Highway 8 NW Saint Paul MN US 55112
30088145583008814558CARDIOVASCULAR SYSTEMS INCORPORATED1N2026-01-0114740 Kirby Dr Houston TX US 77047

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDID, Product, Phone table
Source GUDIDProductPhoneEmail
10852528005817Diamondback Peripheral - Diamondback Peripheral, Exchangeable Series, 1.25 Micro, 145 cm shaft, 140 krpm High Speed, 90 krpm Medium Speed, 60 krpm Low Speed651-259-1600customerservice@csi360.com
10852528005817Diamondback Peripheral - Diamondback Peripheral, Exchangeable Series, 1.25 Micro, 145 cm shaft, 140 krpm High Speed, 90 krpm Medium Speed, 60 krpm Low Speed+1(877)274-0360customerservice@csi360.com
10852528005824Diamondback Peripheral - Diamondback Peripheral, Exchangeable Series, 1.25 Solid, 145 cm shaft, 120 krpm High Speed, 90 krpm Medium Speed, 60 krpm Low Speed651-259-1600customerservice@csi360.com
10852528005824Diamondback Peripheral - Diamondback Peripheral, Exchangeable Series, 1.25 Solid, 145 cm shaft, 120 krpm High Speed, 90 krpm Medium Speed, 60 krpm Low Speed+1(877)274-0360customerservice@csi360.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
1249441297266658P130005DIAMONDBACK 360 CORONARY ORBITAL ATHERECTOMY SYSTEMMCX2013-10-21
1802851297266658P130005DIAMONDBACK 360 CORONARY ORBITAL ATHERECTOMY SYSTEMMCX2013-10-21
1802851649037650K220568Diamondback 360 Peripheral Orbital Atherectomy System, Stealth 360 Peripheral Orbital Atherectomy System, Diamondback 360 Peripheral Orbital Atherectomy System Exchangeable SeriesMCW2022-04-27
1249441649037650K220568Diamondback 360 Peripheral Orbital Atherectomy System, Stealth 360 Peripheral Orbital Atherectomy System, Diamondback 360 Peripheral Orbital Atherectomy System Exchangeable SeriesMCW2022-04-27
1802851295388193K211240ViperCross Support CathetersDQY2021-08-26
1802851295788282K210586Diamonback 360 Peripheral Orbital Atherectomy System, Diamondback 360 Stealth Orbital Atherectomy systemMCW2021-09-14
1249441295788282K210586Diamonback 360 Peripheral Orbital Atherectomy System, Diamondback 360 Stealth Orbital Atherectomy systemMCW2021-09-14
1802851734228358K210282WIRION Embolic Protection SystemNTE2021-03-03
1802851340459919K203008DIAMONDBACK 360 Peripheral Orbital Atherectomy System, DIAMONDBACK 360 Peripheral Orbital Atherectomy System, Exchangeable Series, Stealth 360 Peripheral Orbital Atherectomy SystemMCW2020-11-19
1802851264630936K200198WIRIONNTE2020-03-18
1249441630753771K190634Diamondback 360 Peripheral Orbital Atherectomy System, Stealth 360 Peripheral Orbital Atherectomy SystemMCW2019-07-02
1802851630753771K190634Diamondback 360 Peripheral Orbital Atherectomy System, Stealth 360 Peripheral Orbital Atherectomy SystemMCW2019-07-02
1249441645630776K183000ViperCath XC Peripheral Exchange CatheterDQY2018-12-29
1249441112779326K182397Diamondback 360 Peripheral Orbital Atherectomy System Exchangeable SeriesMCW2018-12-13
1802851112779326K182397Diamondback 360 Peripheral Orbital Atherectomy System Exchangeable SeriesMCW2018-12-13
1802851995554121K180416ViperWire Advance Guide Wire, Stealth 360 Orbital Peripheral Atherectomy Device (PAD), DIAMONDBACK 360 Peripheral Atherectomy SystemMCW2018-04-17
1249441995554121K180416ViperWire Advance Guide Wire, Stealth 360 Orbital Peripheral Atherectomy Device (PAD), DIAMONDBACK 360 Peripheral Atherectomy SystemMCW2018-04-17
1249441778577295K170792Diamondback 360 Peripheral Orbital Atherectomy SystemMCW2017-06-09
1802851778577295K170792Diamondback 360 Peripheral Orbital Atherectomy SystemMCW2017-06-09
1249441543877241K152694Diamondback 360 Peripheral Orbital Atherectomy SystemMCW2015-10-21
1802851543877241K152694Diamondback 360 Peripheral Orbital Atherectomy SystemMCW2015-10-21
1249441536318531K151260ViperWire Advance Guide Wire, Diamondback 360 Peripheral Orbital Atherectomy System, Stealth 360 Orbital PADMCW2015-06-10
1802851536318531K151260ViperWire Advance Guide Wire, Diamondback 360 Peripheral Orbital Atherectomy System, Stealth 360 Orbital PADMCW2015-06-10
1802851975326275K150732Diamondback 360 Peripheral Orbital Atherectomy SystemMCW2015-04-13
1249441975326275K150732Diamondback 360 Peripheral Orbital Atherectomy SystemMCW2015-04-13
1802851141040645K133999DIAMONDBACK 360 PERIPHERAL ORBITAL ATHERECTOMY SYSTEMMCW2014-02-28
1249441141040645K133999DIAMONDBACK 360 PERIPHERAL ORBITAL ATHERECTOMY SYSTEMMCW2014-02-28
1802851361316709K133399DIAMONDBACK 360 PERIPHERAL ORBITAL ATHERECTOMY SYSTEMMCW2013-11-22
1249441361316709K133399DIAMONDBACK 360 PERIPHERAL ORBITAL ATHERECTOMY SYSTEMMCW2013-11-22
1802851128737480K111388DIAMONDBACK 360* ORBITAL ATHERECTOMY SYSTEM, STEALTH 360* ORBITAL PAD SYSTEMMCW2011-07-26
1802851542031674K110389STEALTH 360 ORBITAL PAD SYSTEMMCW2011-03-11
1249441542031674K110389STEALTH 360 ORBITAL PAD SYSTEMMCW2011-03-11
1802851127935789

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
MCW262022-04-27
DQY22021-08-26
NTE22021-03-03
MCX22013-10-21

PMA#

Diamondback 360 Coronary Orbital Atherectomy System

2022-03-11

CARDIOVASCULAR SYSTEMS, INC.651 Campus Drminneapolis, MN 55211 PMA NumberP130005 Supplement NumberS035 Date Received02/18/2022 Decision Date03/11/2022 Product Code MCX  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process...

PMN#

WIRION

2020-03-18

Cardiovascular Systems, Inc

GUDID#

80 records. Showing 1-40. Next