Data / Medical devices / United States / Cardiovascular Systems Incorporated
Cardiovascular Systems Incorporated: FDA-registered device maker in Saint Paul, MN, United States, 18 510(k) clearances and 1 PMA approval
Cardiovascular Systems Incorporated is registered with the FDA (registration 3004742232) in Saint Paul, MN, United States. It lists 5 device types. The FDA files 18 510(k) clearances and 1 PMA approval under its listings, the newest dated April 27, 2022. 15 recall events name it as the recalling firm (3 Class I). Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3004742232
- Address
- 1225 Old Highway 8 NW, Saint Paul, MN, United States, 55112
- Owner or operator
- ABBOTT LABORATORIES (1415939)
- Roles
- Complaint file establishment, Manufacturer, Repackager or relabeler, Specification developer
- First device listed
- September 19, 2008
- Registered through
- 2026
- Brand names listed
- 20 Max Crown, DIAMONDBACK 360 Coronary Orbital Atherectomy System, DIAMONDBACK 360 Peripheral Orbital Atherectomy System, DiamondBack 360 Peripheral Orbital Atherectomy System, DiamondBack 360 Peripheral Orbital Atherectomy System, Exchangeable, Diamondback, Diamondback 360 Peripheral Orbital Atherectomy System Exchangeable Series, Diamondback 360® Peripheral Orbital Atherectomy and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Catheter, Coronary, Atherectomy | MCX | 3 | Manufacturer | accessdata.fda.gov |
| Catheter, Percutaneous | DQY | 2 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Catheter, Peripheral, Atherectomy | MCW | 2 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
| Tape, Measuring, Rulers And Calipers | FTY | 1 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Temporary Carotid Catheter For Embolic Capture | NTE | 2 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| April 27, 2022 | K220568 | Diamondback 360 Peripheral Orbital Atherectomy System, Stealth 360 Peripheral Orbital Atherectomy System, Diamondback 360 Peripheral Orbital Atherectomy System Exchangeable Series | MCW | Substantially Equivalent | Cardiovascualr Systems, Inc. | accessdata.fda.gov |
| September 14, 2021 | K210586 | Diamonback 360 Peripheral Orbital Atherectomy System, Diamondback 360 Stealth Orbital Atherectomy system | MCW | Substantially Equivalent | Cardiovascular Systems, Inc. | accessdata.fda.gov |
| August 26, 2021 | K211240 | ViperCross Support Catheters | DQY | Substantially Equivalent | Cardiovascular Systems, Inc. | accessdata.fda.gov |
| March 3, 2021 | K210282 | WIRION Embolic Protection System | NTE | Substantially Equivalent | Cardiovascular Systems, Inc. | accessdata.fda.gov |
| November 19, 2020 | K203008 | DIAMONDBACK 360 Peripheral Orbital Atherectomy System, DIAMONDBACK 360 Peripheral Orbital Atherectomy System, Exchangeable Series, Stealth 360 Peripheral Orbital Atherectomy System | MCW | Substantially Equivalent | Cardiovascular Systems, Inc. | accessdata.fda.gov |
| March 18, 2020 | K200198 | WIRION | NTE | Substantially Equivalent | Cardiovascular Systems, Inc. | accessdata.fda.gov |
| July 2, 2019 | K190634 | Diamondback 360 Peripheral Orbital Atherectomy System, Stealth 360 Peripheral Orbital Atherectomy System | MCW | Substantially Equivalent | Cardiovascular Systems, Inc. | accessdata.fda.gov |
| December 29, 2018 | K183000 | ViperCath XC Peripheral Exchange Catheter | DQY | Substantially Equivalent | Cardiovascular Systems, Inc. | accessdata.fda.gov |
| December 13, 2018 | K182397 | Diamondback 360 Peripheral Orbital Atherectomy System Exchangeable Series | MCW | Substantially Equivalent | Cardiovascular Systems, Inc. | accessdata.fda.gov |
| April 17, 2018 | K180416 | ViperWire Advance Guide Wire, Stealth 360 Orbital Peripheral Atherectomy Device (PAD), DIAMONDBACK 360 Peripheral Atherectomy System | MCW | Substantially Equivalent | Cardiovascular Systems, Inc. | accessdata.fda.gov |
| June 9, 2017 | K170792 | Diamondback 360 Peripheral Orbital Atherectomy System | MCW | Substantially Equivalent | Cardiovascular Systems, Inc. | accessdata.fda.gov |
| October 21, 2015 | K152694 | Diamondback 360 Peripheral Orbital Atherectomy System | MCW | Substantially Equivalent | Cardiovascular Systems, Inc. | accessdata.fda.gov |
| June 10, 2015 | K151260 | ViperWire Advance Guide Wire, Diamondback 360 Peripheral Orbital Atherectomy System, Stealth 360 Orbital PAD | MCW | Substantially Equivalent | Cardiovascular System, Inc. | accessdata.fda.gov |
| April 13, 2015 | K150732 | Diamondback 360 Peripheral Orbital Atherectomy System | MCW | Substantially Equivalent | Cardiovascular Systems, Inc. | accessdata.fda.gov |
| February 28, 2014 | K133999 | DIAMONDBACK 360 PERIPHERAL ORBITAL ATHERECTOMY SYSTEM | MCW | Substantially Equivalent | Cardiovascular Systems, Inc. | accessdata.fda.gov |
| November 22, 2013 | K133399 | DIAMONDBACK 360 PERIPHERAL ORBITAL ATHERECTOMY SYSTEM | MCW | Substantially Equivalent | Cardiovascular Systems Incorporated | accessdata.fda.gov |
| July 26, 2011 | K111388 | DIAMONDBACK 360* ORBITAL ATHERECTOMY SYSTEM, STEALTH 360* ORBITAL PAD SYSTEM | MCW | Substantially Equivalent | Cardiovascular Systems, Inc. | accessdata.fda.gov |
| March 11, 2011 | K110389 | STEALTH 360 ORBITAL PAD SYSTEM | MCW | Substantially Equivalent | Cardiovascular Systems, Inc. | accessdata.fda.gov |
PMA approvals
Premarket approvals this establishment lists, with the supplements the FDA has decided since.
| Approved | PMA number | Device | Product code | Supplements | Latest decision | Source |
|---|---|---|---|---|---|---|
| October 21, 2013 | P130005 | DIAMONDBACK 360 CORONARY ORBITAL ATHERECTOMY SYSTEM | MCX | 49 | March 10, 2026 | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| November 22, 2021 | 89120 | Class I | Terminated | WIRION EMBOLIC PROTECTION SYSTEM, Delivery Catheter and Filter and Retrieval Catheter, 6Fr, REF (Model Number) WRN-D6 | Under certain circumstances, the WIRION filter assembly may become difficult to withdraw. Under such circumstances, alternative means may be necessary for withdrawal and the device may be prone to tearing or separating which may result in a risk for embolization. | accessdata.fda.gov |
| July 21, 2021 | 88388 | Class II | Terminated | DIAMONDBACK 360 GEN2 PERIPHERAL ORBITAL ATHERECTOMY SYSTEM, 1.5MM SOLID, 145 CM, REF DBP-150SOLID145 | There is a potential mislabeling of the OAD crown sizes: 1.50mm Sold Crown OADs may be packaged s 1.25mm Micro Crown OADs and vice versa. | accessdata.fda.gov |
| April 13, 2018 | 80765 | Class II | Terminated | CSI, Orbital Atherectomy System (OAS) Saline Infusion Pump, Rx only, Part Number: 7-10014, Model Number: SIP-3000. Product Usage: Usage: The pump is a component of the OAS that provides the pumping mechanism and power to | The pumps may switch to stand-by during use requiring the pump to be reset prior to continuing treatment. | accessdata.fda.gov |
| September 14, 2017 | 78897 | Class II | Terminated | Peripheral Diamondback 1.25 Solid OAD, a percutaneous orbital atherectomy system indicated for use as therapy in patients with occlusive atherosclerotic disease in peripheral arteries and who are acceptable candidates fo | Cardiovascular Systems, Inc. (CSI) is removing the products because it was identified that the labeling for two lots of product s were potentially inadvertently switched during production. | accessdata.fda.gov |
| April 14, 2017 | 76953 | Class II | Terminated | CSI, Orbital Atherectomy System (OAS) Saline Infusion Pump, Rx only, Part Number: 7-10014, Model Number: SIP-3000. | Cardiovascular Systems, Inc. (CSI). has initiated a recall to remove 1,396 7-10014 Saline Infusion Pumps (SIP) which were distributed by CSI between 07 April 2015 and 04 April 2017. The 7-10014 pumps may switch to stand-by during use requiring the pump to be reset prior to continuing treatment. To date, none of the associated complaints have resulted in any | accessdata.fda.gov |
| March 3, 2017 | 76784 | Class II | Terminated | ViperWire Advance Peripheral Guide Wire with Flex Tip, Model No. VPR-GW-FT18. Sterilized with Ethylene Oxide. The guide wire is a smooth, stainless steel wire, with a silicone coating, and a radiopaque distal spring tip. | Cardiovascular Systems, Inc. is recalling one lot of ViperWire Advance with Flextip, model VPR-GW-FT18 because it may contain a 0.014" ViperWire Advance Flextip product instead of the 0.018" ViperWire Advance with Flextip. | accessdata.fda.gov |
| February 9, 2017 | 76928 | Class II | Terminated | ViperWire Advance with Flextip Peripheral Atherectomy Guide Wire, Part Number: 7-10026-01,Model Number: VPR-GW-FT14. Product Usage: The Stealth 360 Orbital PAD System and the Diamondback 360 Peripheral Orbital Atherectom | CSI is recalling three lots of VIPERWIRE ADVANCE WITH FLEXTIP PERIPHERAL ATHERECTOMY GUIDEWIRE. It was discovered that 0.018in ViperWire Advance with Flextip product was packaged as a 0.014in ViperWire Advance with Flextip. | accessdata.fda.gov |
| December 7, 2016 | 76352 | Class II | Terminated | DIAMONDBACK 360 Peripheral 1.50 Classic, Model DBP-150CLASS145 Peripheral Orbital Atherectomy System (OAS) is a minimally invasive, catheter-based OAS designed for improving luminal diameter in patients with peripheral a | CSI discovered that a 1.50mm Solid Crown OAD was labeled as a 1.50mm Crown OED. | accessdata.fda.gov |
| June 13, 2016 | 74445 | Class II | Terminated | ViperWire Advance Peripheral Guide Wire, Sterilized with Ethylene Oxide, Rx Only. Part number 72023-02, Model Number VPR-GW-17. Five (5) guide wire pouches in one (1) guide wire box. For use with CSI Peripheral Orbital A | The pouch label was missing the use by date (UBD) of 2018-04. | accessdata.fda.gov |
| March 4, 2015 | 70727 | Class I | Terminated | Diamondback 360 Coronary Orbital Atherectomy System, Model Number: DBEC-125. The system is indicated to facilitate stent delivery in patients with coronary artery disease (CAD) who are acceptable candidates for PTCA or s | The OAD saline sheath outer layer may flake off from the catheter due to friction between the outer material layer and corresponding materials it may come in contact with during clinical use. If the material is large enough, it has the potential to cause a flow limiting embolism. | accessdata.fda.gov |
| May 23, 2014 | 68806 | Class I | Terminated | CSI Cardiovascular Systems, Inc., Diamondback 360 Peripheral Orbital Atherectomy System, Model Number DBP-125MICRO145, Part Number 7-10003. The Diamondback 360 Peripheral Orbital Atherectomy System is a percutaneous orbi | CSI has initiated a recall on the Diamondback 360 Peripheral Orbital Atherectomy Device because it may contain a saline sheath that may experience cracking, fracture, and release particulate during use. | accessdata.fda.gov |
| January 27, 2014 | 67445 | Class III | Terminated | CSI, Diamondback 360 Coronary Orbital Atherectomy System, Part Number 70058-02, Model Number DBEC-125 Product Usage: The system is indicated to facilitate stent delivery in patients with coronary artery disease (CAD) who | Cardio vascular Systems Inc. has initiated a recall to request the immediate removal and return of Diamondback 360 Coronary Orbital Atherectomy Device (OAD). The device mistakenly contains a saline line that is used in our peripheral atherectomy device. This saline line was not part of the FDA approval for use in the coronary device. It therefore does not me | accessdata.fda.gov |
| June 18, 2012 | 62406 | Class II | Terminated | CSI Stealth 360-degree Orbital Atherectomy Device (OAD), Part Number 70056-11, Model Number PRD-SC30-125S. Sterilized with Ethylene Oxide. The Stealth 360-degree Orbital Atherectomy Device (OAD) is part of the Stealth 36 | CSI has initiated a recall on specific lot numbers of Stealth 360-degree Orbital Atherectomy devices which have the potential for an insufficient crown solder bond that may result in the crown becoming detached from the driveshaft. | accessdata.fda.gov |
| April 16, 2009 | 52810 | Not yet classified | Terminated | Diamondback 360 Orbital Atherectomy Device, 1.50 LT Classic, Model #DB-150L, CSI Part # 70025-02 Expiration 2012-02, Sterilized with Ethylene Oxide, Cardiovascular Systems, Inc., St. Paul, MN USA. The Diamondback 360 OAD | CSI is correcting (8) packages of Diamondback 360 due to a missing "Use By Date" on the device labeling. The labelling should have been a 12 month shelf life (2010-02) rather than no information for shelf life. The units affected by this correction are sterilized products, and CSI believes that there is no immediate risk to health associated with these distr | accessdata.fda.gov |
| March 16, 2009 | 51499 | Not yet classified | Terminated | Diamondback 360, CSI ViperWire Orbital Atherectomy Guide Wire, REF: GW14335FRM. Sterilized with Ethylene Oxide. Manufactured for Cardiovascular Systems, Inc., St. Paul, MN 55112, USA. The ViperWire atherectomy guide wire | CSI is recalling 10 devices due to a mislabeling of the shelf life as shown on the device labeling. The labeling shown on the affected devices represents a 24 month shelf life rather than a 6 month shelf life that should have been indicated. | accessdata.fda.gov |
Compare with other makers
- All makers of Temporary Carotid Catheter For Embolic Capture
- All makers of Catheter, Coronary, Atherectomy
- All makers of Catheter, Peripheral, Atherectomy
- All makers of Catheter, Percutaneous
- All makers of Tape, Measuring, Rulers And Calipers
Updated March 10, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.