Data / Medical devices / United States / Cardiovascular Systems Incorporated
Cardiovascular Systems Incorporated: FDA-registered device maker in Houston, TX, United States, 13 510(k) clearances and 1 PMA approval
Cardiovascular Systems Incorporated is registered with the FDA (registration 3008814558) in Houston, TX, United States. It lists 3 device types. The FDA files 13 510(k) clearances and 1 PMA approval under its listings, the newest dated April 27, 2022. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3008814558
- Address
- 14740 Kirby Dr, Houston, TX, United States, 77047
- Owner or operator
- ABBOTT LABORATORIES (1415939)
- Roles
- Manufacturer
- First device listed
- November 29, 2011
- Registered through
- 2026
- Brand names listed
- 20 Max Crown, DIAMONDBACK 360 Coronary Orbital Atherectomy System, DIAMONDBACK 360 Peripheral Orbital Atherectomy System, Diamondback, Diamondback 360 Peripheral Orbital Atherectomy System Exchangeable Series, Diamondback 360® Peripheral Orbital Atherectomy, Diamondback OAS, Diamondback Peripheral Micro and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Catheter, Coronary, Atherectomy | MCX | 3 | Manufacturer | accessdata.fda.gov |
| Catheter, Percutaneous | DQY | 2 | Manufacturer | accessdata.fda.gov |
| Catheter, Peripheral, Atherectomy | MCW | 2 | 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 |
| 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 |
| 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 |
Compare with other makers
- All makers of Catheter, Peripheral, Atherectomy
- All makers of Catheter, Coronary, Atherectomy
- All makers of Catheter, Percutaneous
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.