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.

USA

NASDAQ

CSII

DUNS 024954518

FDA Registration(s)

• Registration Number: 3008814558
• FEI Number: 3008814558
• Name: CARDIOVASCULAR SYSTEMS INCORPORATED
• Owner & Operator: CARDIOVASCULAR SYSTEMS INCORPORATED
• Contact Address: 1225 Old Hwy 8 NW --; Saint Paul MN 55112 US
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: 14740 Kirby Dr ; Houston, TX 77047 US
• Establishment Type:
  • Manufacture Medical Device
  • Complaint File Establishment per 21 CFR 820.198

• Registration Number: 3004742232
• FEI Number: 3004742232
• Name: Cardiovascular Systems Incorporated
• Owner & Operator: CARDIOVASCULAR SYSTEMS INCORPORATED
• Contact Address: 1225 Old Hwy 8 NW --; Saint Paul MN 55112 US
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: 1225 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	Device	Date
GUDID 30852528005125 Cardiovascular Systems, Inc.	Viperslide 72031-01	2025-07-17
GUDID 30852528005118 Cardiovascular Systems, Inc.	ViperTrack 72029-01	2025-07-17
GUDID 30852528005101 Cardiovascular Systems, Inc.	ViperTrack 72014-02	2025-07-17
GUDID 10852528005992 Cardiovascular Systems, Inc.	Diamondback Peripheral 7-10031-08	2025-07-17
GUDID 10852528005985 Cardiovascular Systems, Inc.	Diamondback Peripheral 7-10031-07	2025-07-17
GUDID 10852528005978 Cardiovascular Systems, Inc.	Diamondback Peripheral 7-10031-06	2025-07-17
GUDID 10852528005961 Cardiovascular Systems, Inc.	Diamondback Peripheral 7-10031-05	2025-07-17
GUDID 10852528005954 Cardiovascular Systems, Inc.	Diamondback Peripheral 7-10031-04	2025-07-17
GUDID 10852528005947 Cardiovascular Systems, Inc.	Diamondback Peripheral 7-10031-03	2025-07-17
GUDID 10852528005930 Cardiovascular Systems, Inc.	Diamondback Peripheral 7-10031-02	2025-07-17
GUDID 10852528005923 Cardiovascular Systems, Inc.	Diamondback Peripheral 7-10031-01	2025-07-17
GUDID 10852528005916 Cardiovascular Systems, Inc.	Diamondback Peripheral 7-10030-11	2025-07-17
GUDID 10852528005909 Cardiovascular Systems, Inc.	Diamondback Peripheral 7-10030-10	2025-07-17
GUDID 10852528005893 Cardiovascular Systems, Inc.	Diamondback Peripheral 7-10030-09	2025-07-17
GUDID 10852528005886 Cardiovascular Systems, Inc.	Diamondback Peripheral 7-10030-08	2025-07-17
GUDID 10852528005879 Cardiovascular Systems, Inc.	Diamondback Peripheral 7-10030-07	2025-07-17
GUDID 10852528005862 Cardiovascular Systems, Inc.	Diamondback Peripheral 7-10030-06	2025-07-17
GUDID 10852528005848 Cardiovascular Systems, Inc.	Diamondback Peripheral 7-10030-04	2025-07-17
GUDID 10852528005831 Cardiovascular Systems, Inc.	Diamondback Peripheral 7-10030-03	2025-07-17
GUDID 10852528005824 Cardiovascular Systems, Inc.	Diamondback Peripheral 7-10030-02	2025-07-17
GUDID 10852528005817 Cardiovascular Systems, Inc.	Diamondback Peripheral 7-10030-01	2025-07-17
GUDID 10852528005770 Cardiovascular Systems, Inc.	Stealth 7-10058-03	2025-07-17
GUDID 10852528005763 Cardiovascular Systems, Inc.	Stealth 7-10058-02	2025-07-17
GUDID 10852528005756 Cardiovascular Systems, Inc.	Stealth 7-10058-01	2025-07-17
GUDID 10852528005343 Cardiovascular Systems, Inc.	Stealth 70056-07	2025-07-17
GUDID 10852528005275 Cardiovascular Systems, Inc.	Diamondback Peripheral DBP–200SOLID145	2025-07-17
GUDID 10852528005190 Cardiovascular Systems, Inc.	Diamondback Peripheral DBP-125MICRO145	2025-07-17
GUDID 10852528005138 Cardiovascular Systems, Inc.	Diamondback Coronary 70057-03	2025-07-17
GUDID 10852528005091 Cardiovascular Systems, Inc.	ViperTrack 72014-01	2025-07-17
GUDID 10852528005060 Cardiovascular Systems, Inc.	Stealth 70056-11	2025-07-17
GUDID 10852528005053 Cardiovascular Systems, Inc.	Stealth 70056-06	2025-07-17
GUDID 10852528005046 Cardiovascular Systems, Inc.	Stealth 70056-04	2025-07-17
GUDID 10852528005039 Cardiovascular Systems, Inc.	Stealth 70056-03	2025-07-17
GUDID 10852528005022 Cardiovascular Systems, Inc.	Stealth 70056-02	2025-07-17
GUDID 10852528005015 Cardiovascular Systems, Inc.	Stealth 70056-01	2025-07-17
GUDID 10852528005008 Cardiovascular Systems, Inc.	Diamondback Peripheral 7-10031-09	2025-07-17
GUDID 10850000491035 Cardiovascular Systems, Inc.	Diamondback Peripheral 7-10032-01	2025-07-17
GUDID 10850000491028 Cardiovascular Systems, Inc.	Diamondback Peripheral 7-10031-11	2025-07-17
GUDID 10850000491011 Cardiovascular Systems, Inc.	Diamondback Peripheral 7-10031-10	2025-07-17
GUDID 10852528005282 Cardiovascular Systems, Inc.	Diamondback Peripheral 7-10024	2025-06-19
GUDID 10852528005268 Cardiovascular Systems, Inc.	Diamondback Peripheral 7-10017	2025-06-19
GUDID 10852528005251 Cardiovascular Systems, Inc.	Diamondback Peripheral 7-10016	2025-06-19
GUDID 10852528005244 Cardiovascular Systems, Inc.	Diamondback Peripheral 7-10012	2025-06-19
GUDID 10852528005237 Cardiovascular Systems, Inc.	Diamondback Peripheral 7-10011	2025-06-19
GUDID 10852528005213 Cardiovascular Systems, Inc.	Diamondback Peripheral 7-10002	2025-06-19
GUDID 10852528005206 Cardiovascular Systems, Inc.	Diamondback Peripheral 7-10001	2025-06-19
GUDID 10852528005855 Cardiovascular Systems, Inc.	Diamondback Peripheral 7-10030-05	2025-06-17
GUDID 10852528005374 Cardiovascular Systems, Inc.	Diamondback Peripheral 7-10029-03	2025-06-17
GUDID 10852528005367 Cardiovascular Systems, Inc.	Diamondback Peripheral 7-10029-02	2025-06-17
GUDID 10852528005350 Cardiovascular Systems, Inc.	Diamondback Peripheral 7-10029-01	2025-06-17
GUDID 30852528005187 Cardiovascular Systems, Inc.	Diamondback Coronary 72010-01	2023-12-18
GUDID 10852528005800 Cardiovascular Systems, Inc.	Diamondback Coronary 7-10037-07	2023-12-18
GUDID 10852528005787 Cardiovascular Systems, Inc.	Diamondback Coronary 70058-13	2023-12-18
GUDID 10852528005428 Cardiovascular Systems, Inc.	Diamondback Coroanry 70058-12	2023-12-18
GUDID 10852528005336 Cardiovascular Systems, Inc.	Diamondback Coronary 7-10000-01	2023-12-18
GUDID 10852528005176 Cardiovascular Systems, Inc.	Diamondback Coronary 70058-03	2023-12-18
GUDID 10852528005169 Cardiovascular Systems, Inc.	Diamondback Coronary 70058-02	2023-12-18
GUDID 10852528005442 Cardiovascular Systems, Inc.	Diamondback Coronary 7-10037-01	2023-12-11
GUDID 10850026568698 Cardiovascular Systems, Inc.	Diamondback Coronary 7-10098-01	2023-06-26
GUDID 10850026568711 Cardiovascular Systems, Inc.	STEALTH 7-10059-46	2022-07-11
GUDID 10850026568476 Cardiovascular Systems, Inc.	DIAMONDBACK 7-10030-13	2022-07-11
GUDID 10850026568469 Cardiovascular Systems, Inc.	DIAMONDBACK 7-10031-13	2022-07-11
GUDID 10850026568445 Cardiovascular Systems, Inc.	DIAMONDBACK 7-10057-10	2022-07-11
GUDID 30850026568685 Cardiovascular Systems, Inc.	Shepherd 7-10097-08	2022-05-30
GUDID 30850026568678 Cardiovascular Systems, Inc.	Shepherd 7-10097-07	2022-05-30
GUDID 30850026568661 Cardiovascular Systems, Inc.	Shepherd 7-10097-06	2022-05-30
GUDID 30850026568654 Cardiovascular Systems, Inc.	Shepherd 7-10097-05	2022-05-30
GUDID 30850026568647 Cardiovascular Systems, Inc.	Shepherd 7-10097-04	2022-05-30
GUDID 30850026568630 Cardiovascular Systems, Inc.	Shepherd 7-10097-03	2022-05-30
GUDID 30850026568623 Cardiovascular Systems, Inc.	Shepherd 7-10097-02	2022-05-30
GUDID 30850026568616 Cardiovascular Systems, Inc.	Shepherd 7-10097-01	2022-05-30
GUDID 30850026568609 Cardiovascular Systems, Inc.	Shepherd 7-10096-08	2022-05-30
GUDID 30850026568593 Cardiovascular Systems, Inc.	Shepherd 7-10096-07	2022-05-30
GUDID 30850026568586 Cardiovascular Systems, Inc.	Shepherd 7-10096-06	2022-05-30
GUDID 30850026568579 Cardiovascular Systems, Inc.	Shepherd 7-10096-05	2022-05-30
GUDID 30850026568562 Cardiovascular Systems, Inc.	Shepherd 7-10096-04	2022-05-30
GUDID 30850026568555 Cardiovascular Systems, Inc.	Shepherd 7-10096-03	2022-05-30
GUDID 30850026568531 Cardiovascular Systems, Inc.	Shepherd 7-10096-01	2022-05-30
GUDID 10850026568544 Cardiovascular Systems, Inc.	Shepherd 7-10096-02	2022-05-30
GUDID 30852528005590 Cardiovascular Systems, Inc.	ZILIENT 7-10050-07	2021-12-22
GUDID 30852528005583 Cardiovascular Systems, Inc.	ZILIENT 7-10050-06	2021-12-22
GUDID 30852528005576 Cardiovascular Systems, Inc.	ZILIENT 7-10050-05	2021-12-22
GUDID 30852528005569 Cardiovascular Systems, Inc.	ZILIENT 7-10050-04	2021-12-22
GUDID 30852528005552 Cardiovascular Systems, Inc.	ZILIENT 7-10050-03	2021-12-22
GUDID 30852528005545 Cardiovascular Systems, Inc.	ZILIENT 7-10050-02	2021-12-22
GUDID 30852528005538 Cardiovascular Systems, Inc.	ZILIENT 7-10050-01	2021-12-22
GUDID 30852528005521 Cardiovascular Systems, Inc.	ZILIENT 7-10049-08	2021-12-22
GUDID 30852528005514 Cardiovascular Systems, Inc.	ZILIENT 7-10049-07	2021-12-22
GUDID 30852528005507 Cardiovascular Systems, Inc.	ZILIENT 7-10049-06	2021-12-22
GUDID 30852528005491 Cardiovascular Systems, Inc.	ZILIENT 7-10049-05	2021-12-22
GUDID 30852528005484 Cardiovascular Systems, Inc.	ZILIENT 7-10049-04	2021-12-22
GUDID 30852528005453 Cardiovascular Systems, Inc.	Extended Length ViperWire Advance 7-10035-01	2021-12-22
GUDID 30852528005392 Cardiovascular Systems, Inc.	Extended Length ViperWire Advance	2021-12-22
GUDID 30852528005323 Cardiovascular Systems, Inc.	ViperWire Advance FlexTip VPR-GW-FT18	2021-12-22
GUDID 30852528005316 Cardiovascular Systems, Inc.	ViperWire Advance FlexTip VPR-GW-FT14	2021-12-22
GUDID 30852528005224 Cardiovascular Systems, Inc.	ViperWire VPR-GW-200	2021-12-22
GUDID 30852528005088 Cardiovascular Systems, Inc.	ViperWire, Advance 72023-02	2021-12-22
GUDID 30852528005071 Cardiovascular Systems, Inc.	ViperWire, Advance 72023-01	2021-12-22
GUDID 10852528005473 Cardiovascular Systems, Inc.	ZILIENT 7-10049-03	2021-12-22
GUDID 10852528005466 Cardiovascular Systems, Inc.	Extended Length ViperWire Advance 7-10035-02	2021-12-22
PMN K212725 Cardiovascular Systems, Inc.	ViperCross Support Catheters	2021-09-24
PMN K211240 Cardiovascular Systems, Inc.	ViperCross Support Catheters	2021-08-26
PMN K211251 Cardiovascular Systems, Inc.	ViperCath XC Peripheral Exchange Catheter	2021-05-26
PMA P130005S033 CARDIOVASCULAR SYSTEMS, INC.	DIAMONDBACK 360 Coronary Orbital Atherectomy System (OAS)	2021-04-23
PMN K210282 Cardiovascular Systems Inc.	WIRION Embolic Protection System	2021-03-03
PMA P130005S032 CARDIOVASCULAR SYSTEMS, INC.	DIAMONDBACK 360 Coronary Orbital Atherectomy System (OAS)	2021-01-14
PMA P130005S031 CARDIOVASCULAR SYSTEMS, INC.	DIAMONDBACK 360 Coronary Orbital Atherectomy System (OAS)	2020-12-10
PMA P130005S030 CARDIOVASCULAR SYSTEMS, INC.	Diamondback 360 Coronary Orbital Atherectomy System (OAS)	2020-07-15
PMA P130005S029 CARDIOVASCULAR SYSTEMS, INC.	DIAMONDBACK 360 Coronary Orbital Atherectomy System (OAS)	2020-06-18
PMN K200198 | NTE Cardiovascular Systems Incorporated	WIRION	2020-04-03
PMN K200198 Cardiovascular Systems, Inc	WIRION	2020-03-18
PMA P130005S028 CARDIOVASCULAR SYSTEMS, INC.	Diamondback 360 Coronary Orbital Atherectomy System (OAS)	2020-02-24
PMN K190634 | MCW Cardiovascular Systems Incorporated	Stealth OAS	2019-10-30
PMN K190634 | MCW Cardiovascular Systems Incorporated	Diamondback OAS	2019-10-30
PMN K190634 | MCW CARDIOVASCULAR SYSTEMS INCORPORATED	Stealth OAS	2019-10-30
PMN K190634 | MCW CARDIOVASCULAR SYSTEMS INCORPORATED	Diamondback OAS	2019-10-30
PMN K182397 | MCW Cardiovascular Systems Incorporated	Diamondback 360 Peripheral Orbital Atherectomy System Exchangeable Series	2019-10-30
PMN K182397 | MCW CARDIOVASCULAR SYSTEMS INCORPORATED	Diamondback 360 Peripheral Orbital Atherectomy System Exchangeable Series	2019-10-30
PMA P130005S027 CARDIOVASCULAR SYSTEMS, INC.	DIAMONDBACK 360 Coronary Orbital Atherectomy System	2019-10-09
PMA P130005S021 CARDIOVASCULAR SYSTEMS, INC.	Diamondback 360 Coronary Orbital Atherectomy System	2019-09-19
PMN K190634 Cardiovascular Systems Inc.	Diamondback 360 Peripheral Orbital Atherectomy System, Stealth 360 Peripheral Orbital Atherectomy System	2019-07-02
PMA P130005S025 CARDIOVASCULAR SYSTEMS, INC.	Diamondback 360 Coronary Orbital Atherectomy (OAD); Orbital Atherectomy System Pump (OAS Pump)ViperWire Advance C	2019-04-10
PMN K183000 | DQY CARDIOVASCULAR SYSTEMS INCORPORATED	ViperCath XC Peripheral Exchange Catheter	2019-01-03
PMN K183000 Cardiovascular Systems, Inc.	ViperCath XC Peripheral Exchange Catheter	2018-12-29
PMN K182397 Cardiovascular Systems Inc.	Diamondback 360 Peripheral Orbital Atherectomy System Exchangeable Series	2018-12-13
PMN K170792 | MCW Cardiovascular Systems Incorporated	Diamondback	2018-12-12
PMN K170792 | MCW CARDIOVASCULAR SYSTEMS INCORPORATED	Diamondback	2018-12-12
PMA P130005S022 CARDIOVASCULAR SYSTEMS, INC.	DIAMONDBACK 360 Coronary Orbital Atherectomy System	2018-10-04
PMN K180416 | MCW Cardiovascular Systems Incorporated	Viperwire Advance with Flextip	2018-06-15
PMN K180416 | MCW CARDIOVASCULAR SYSTEMS INCORPORATED	Viperwire Advance with Flextip	2018-06-15
PMA P130005S024 CARDIOVASCULAR SYSTEMS, INC.	Diamondback 360 Coronary Orbital Atherectomy System	2018-06-12
PMN K180416 Cardiovascular Systems Inc.	ViperWire Advance Guide Wire, Stealth 360 Orbital Peripheral Atherectomy Device (PAD), DIAMONDBACK 360 Peripheral Atherectomy System	2018-04-17
PMA P130005S019 CARDIOVASCULAR SYSTEMS, INC.	Diamond Back 360 Coronary Orbital Atherectomy System	2018-02-09
PMA P130005S020 CARDIOVASCULAR SYSTEMS, INC.	Diamondback 360 Coronary Orbital Atherectomy System (OAS) Micro Crown Orbital Atherectomy (OAD)	2017-11-17
PMA P130005S018 CARDIOVASCULAR SYSTEMS, INC.	DIAMONDBACK 360 Coronary Orbital Atherectomy System (OAS) Classic Crown	2017-10-20
PMA P130005S017 CARDIOVASCULAR SYSTEMS, INC.	DIAMONDBACK 360 Orbital Atherectomy System	2017-08-02
PMN K170792 Cardiovascular Systems, Inc.	Diamondback 360 Peripheral Orbital Atherectomy System	2017-06-09
PMA P130005S016 CARDIOVASCULAR SYSTEMS, INC.	Diamondback 360 Coronary Orbital Atherectomy (OAD)	2017-05-03
PMA P130005S014 CARDIOVASCULAR SYSTEMS, INC.	DIAMONDBACK 360 CORONARY ORBITAL ATHERECTOMY DEVICE (OAD), ORBITAL ATHERECTOMY SYSTEM PUMP (OAS PUMP), VIPERWIRE ADVANCE	2017-03-19
PMA P130005S015 CARDIOVASCULAR SYSTEMS, INC.	DIAMONDBACK 360 CORONARY ORBITAL ATHERECTOMY SYSTEM	2017-02-23
PMA P130005S012 CARDIOVASCULAR SYSTEMS, INC.	DIAMONDBACK 360 CORONARY ORBITAL ATHERECTOMY SYSTEM	2016-10-26
PMA P130005S013 CARDIOVASCULAR SYSTEMS, INC.	DIAMONDBACK 360 CORONARY ORBITAL ATHERECTOMY SYSTEM	2016-06-07
PMA P130005S011 CARDIOVASCULAR SYSTEMS, INC.	DIAMONDBACK 360 CORONARY ORBITAL ATHERECTOMY SYSTEM	2016-03-16
PMA P130005S010 CARDIOVASCULAR SYSTEMS, INC.	DIAMONDBACK 360 CORONARY ORBITAL ATHERECTOMY DEVICE (OAD), ORBITAL ATHERECTOMY SYSTEM PUMP (OAS PUMP), VIPERWIRE ADVANCE	2016-01-21
PMN K152694 | MCW Cardiovascular Systems Incorporated	DIAMONDBACK 360 Peripheral Orbital Atherectomy System	2015-12-04
PMN K152694 | MCW CARDIOVASCULAR SYSTEMS INCORPORATED	DIAMONDBACK 360 Peripheral Orbital Atherectomy System	2015-12-04
PMN K151260 | MCW Cardiovascular Systems Incorporated	VIPERWIRE ADVANCE with FLEXTIP Peripheral Atherectomy Guidewire	2015-12-04
PMN K151260 | MCW CARDIOVASCULAR SYSTEMS INCORPORATED	VIPERWIRE ADVANCE with FLEXTIP Peripheral Atherectomy Guidewire	2015-12-04
PMN K150732 | MCW Cardiovascular Systems Incorporated	DIAMONDBACK 360 Peripheral Orbital Atherectomy System	2015-12-04
PMN K150732 | MCW CARDIOVASCULAR SYSTEMS INCORPORATED	DIAMONDBACK 360 Peripheral Orbital Atherectomy System	2015-12-04
PMA P130005S007 CARDIOVASCULAR SYSTEMS, INC.	DIAMONDBACK 360 CORONARY ORBITAL ATHERECTOMY SYSTEM	2015-11-30
PMN K152694 Cardiovascular Systems Inc.	Diamondback 360 Peripheral Orbital Atherectomy System	2015-10-21
PMA P130005S005 CARDIOVASCULAR SYSTEMS, INC.	DIAMONDBACK 360 CORONARY ORBITAL ATHERECTOMY SYSTEM (OAS)	2015-07-07
PMA P130005S009 CARDIOVASCULAR SYSTEMS, INC.	DIAMONDBACK 360 CORONARY ORBITAL ATHERECTOMY SYSTEM (OAS)	2015-06-25
PMA P130005S008 CARDIOVASCULAR SYSTEMS, INC.	DIAMONDBACK 360 CORONARY ORIBITAL ATHERECTOMY SYSTEM (OAS)	2015-06-25
PMA P130005S004 CARDIOVASCULAR SYSTEMS, INC.	DIAMONDBACK 360 CORONARY ORBITAL ATHERECTOMY SYSTEM (OAS)	2015-05-14
PMN K150732 CARDIOVASCULAR SYSTEMS, INC.	Diamondback 360 Peripheral Orbital Atherectomy System	2015-04-13
PMA P130005S006 CARDIOVASCULAR SYSTEMS, INC.	DIAMONDBACK 360 CORONARY ORIBITAL ATHERECTOMY SYSTEMS (OAS)	2015-03-18
PMA P130005S002 CARDIOVASCULAR SYSTEMS, INC.	DIAMONDBACK 360 CORONARY ORBITAL ATHERECTOMY SYSTEM (OAS)	2015-02-12
PMN K133999 | MCW Cardiovascular Systems Incorporated	Diamondback Peripheral Micro	2014-10-31
PMN K133999 | MCW CARDIOVASCULAR SYSTEMS INCORPORATED	Diamondback Peripheral Micro	2014-10-31
PMN K133399 | MCW Cardiovascular Systems Incorporated	Diamondback Peripheral Micro	2014-10-31
PMN K133399 | MCW CARDIOVASCULAR SYSTEMS INCORPORATED	Diamondback Peripheral Micro	2014-10-31
PMA P130005S001 CARDIOVASCULAR SYSTEMS, INC.	DIAMONDBACK 360 CONONARY ORBITAL ATHERECTOMY SYSTEM	2014-10-29
PMA P130005S003 CARDIOVASCULAR SYSTEMS, INC.	DIAMONDBACK 360 CORONARY ORBITAL ATHERECTOMY SYSTEM	2014-09-26
PMN K133999 CARDIOVASCULAR SYSTEMS, INC.	DIAMONDBACK 360 PERIPHERAL ORBITAL ATHERECTOMY SYSTEM	2014-02-28
PMN K133399 CARDIOVASCULAR SYSTEMS INCORPORATED	DIAMONDBACK 360 PERIPHERAL ORBITAL ATHERECTOMY SYSTEM	2013-11-22
PMN P130005 | MCX Cardiovascular Systems Incorporated	DIAMONDBACK 360 Coronary Orbital Atherectomy System	2013-10-28
PMN P130005 | MCX CARDIOVASCULAR SYSTEMS INCORPORATED	DIAMONDBACK 360 Coronary Orbital Atherectomy System	2013-10-28
PMA P130005 CARDIOVASCULAR SYSTEMS, INC.	DIAMONDBACK 360 CORONARY ORBITAL ATHERECTOMY SYSTEM	2013-10-21
PMN K122987 CARDIOVASCULAR SYSTEMS, INC.	STEALTH 360 ORBITAL PAD SYSTEM	2012-10-25
PMN K111388 | MCW Cardiovascular Systems Incorporated	ViperSlide Lubricant	2012-01-16
PMN K110389 | MCW Cardiovascular Systems Incorporated	Stealth 360 PAD System	2011-11-29
PMN K110389 | MCW CARDIOVASCULAR SYSTEMS INCORPORATED	Stealth 360 PAD System	2011-11-29
PMN K111388 CARDIOVASCULAR SYSTEMS, INC.	DIAMONDBACK 360* ORBITAL ATHERECTOMY SYSTEM, STEALTH 360* ORBITAL PAD SYSTEM	2011-07-26
PMN K110389 CARDIOVASCULAR SYSTEMS, INC.	STEALTH 360 ORBITAL PAD SYSTEM	2011-03-11
PMN K090521 CARDIOVASCULAR SYSTEMS, INC.	DIAMONDBACK 360 DBX	2009-03-20
PMN K083139 CARDIOVASCULAR SYSTEMS, INC.	VIPERSPHERE PTA BALLOON CATHETER	2008-11-25
PMN K082981 CARDIOVASCULAR SYSTEMS, INC.	DIAMONDBACK 360 DEGREE ORBITAL ATHERECTOMY SYSTEM WITH VIPERSLIDE LUBRICANT	2008-10-31
FTY Cardiovascular Systems Incorporated	ViperTrack	2008-09-19
PMN K072748 CARDIOVASCULAR SYSTEMS, INC.	MODIFICATION TO: DIAMONDBACK 360 ORBITAL ATHERECTOMY SYSTEM	2007-11-09
PMN K072800 CARDIOVASCULAR SYSTEMS, INC.	DIAMONDBACK 360 DEGREE ORBITAL ATHERECTOMY SYSTEM	2007-10-25
PMN K071427 CARDIOVASCULAR SYSTEMS, INC.	DIAMONDBACK 360 DEGREE ORBITAL ATHERECTOMY SYSTEM FOR TREATMENT OF A-V SHUNT STENOSIS	2007-08-30
PMN K071350 CARDIOVASCULAR SYSTEMS, INC.	DIAMONDBACK 360 DEGREE ORBITAL ATHERECTOMY SYSTEM	2007-08-22
PMN K041630 CARDIOVASCULAR SYSTEMS INCORPORATED	ORBITAL ATHERECTOMY SYSTEM FOR TREATMENT OF A-V SHUNT STENOSIS	2005-01-31

Similar & Related FDA Registered Companies

• CARDIOVASCULAR IMAGING SYSTEMS, INC.
• 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 Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No

Related Finance Registrations

NCAGE Code	56GP1	CARDIOVASCULAR SYSTEMS INC
NCAGE Code	1UDM9	CARDIOVASCULAR SYSTEMS, INC.!DBA CSI
NCAGE Code	74H28	CARDIOVASCULAR SYSTEMS, INC.!DBA USE CAGE CODE 1UDM9 FOR!CATALOGING
CAGE Code	1UDM9	CARDIOVASCULAR SYSTEMS, INC. CSI
CAGE Code	56GP1	CARDIOVASCULAR SYSTEMS INC
CAGE Code	74H28	CARDIOVASCULAR SYSTEMS, INC. USE CAGE CODE 1UDM9 FOR CATALOGING
S.A.M. Registration	1UDM9 [24954518]	CARDIOVASCULAR SYSTEMS, INC. CSI
DUNS	781105734	CARDIOVASCULAR SYSTEMS INC
SEC	0001180145	Cardiovascular Systems Inc of DELAWARE