# Cardiovascular Systems, Inc.

- Location (FDA's records): St.Paul, MN
- FDA decisions: 29 (2005–2022): 28 510(k) clearances and 1 original PMA approval
- Names in FDA's records: Cardiovascular Systems, Inc. (27); Cardiovascular Systems Incorporated (2)
- Product codes: MCW (21), DQY (5), NTE (2), MCX (1)
- 510(k) review time since 2016: median 73 days, against 97 for FDA's reviews in the same codes and years (7 of 10 faster)
- Predicates its devices cite: 55 (37 its own); citations of its devices by later devices: 48 (37 its own)
- Recalls linked to its devices: 13 (3 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Cardio Systems, Inc.: 4 (https://510kreport.com/company/cardio-systems)
- Boston Scientific Corp: 2 (https://510kreport.com/company/boston-scientific)
- Heart Technology, Inc.: 2 (https://510kreport.com/company/heart-technology)
- Terumo Medical Corp.: 1 (https://510kreport.com/company/terumo-medical)
- Infinity Extrusion & Engineering, Inc.: 1 (https://510kreport.com/company/infinity-extrusion-engineering)
- Cordis Corp.: 1 (https://510kreport.com/company/cordis)
- Invatec Innovative Technologies, S.R.L.: 1 (https://510kreport.com/company/invatec-innovative-technologies)
- Vascular Solutions, Inc.: 1 (https://510kreport.com/company/vascular-solutions)

## Firms that cite its devices most
- Cardio Systems, Inc.: 4 (https://510kreport.com/company/cardio-systems)
- Cardiovascular System, Inc.: 4 (https://510kreport.com/company/cardiovascular-system)
- Cardio Flow Inc.,: 1 (https://510kreport.com/company/cardio-flow)
- C.R. Bard, Inc.: 1 (https://510kreport.com/company/cr-bard)
- Cardiovascualr Systems, Inc.: 1 (https://510kreport.com/company/cardiovascualr-systems)

## Its most-cited devices
- K110389: Stealth 360 Orbital Pad System (2011), cited by 9
- K071350: Diamondback 360 Degree Orbital Atherectomy System (2007), cited by 6
- K122987: Stealth 360 Orbital Pad System (2012), cited by 5
- K090521: Diamondback 360 DBX (2009), cited by 3
- K152694: Diamondback 360 Peripheral Orbital Atherectomy System (2015), cited by 3
- K071427: Diamondback 360 Degree Orbital Atherectomy System for Treatment of a-V Shunt Stenosis (2007), cited by 3

## Recent decisions
- K220109: DIAMONDBACK 360 Peripheral Orbital Atherectomy System, DIAMONDBACK 360 Peripheral Orbital Atherectomy System, Exchangeable Series, Stealth 360 Peripheral Orbital Atherectomy System (Mar 1, 2022)
- K212725: ViperCross Support Catheters (Sep 24, 2021)
- K210586: Diamonback 360 Peripheral Orbital Atherectomy System, Diamondback 360 Stealth Orbital Atherectomy system (Sep 14, 2021)
- K211240: ViperCross Support Catheters (Aug 26, 2021)
- K211251: ViperCath XC Peripheral Exchange Catheter (May 26, 2021)
- K210282: WIRION Embolic Protection System (Mar 3, 2021)
- K203008: DIAMONDBACK 360 Peripheral Orbital Atherectomy System, DIAMONDBACK 360 Peripheral Orbital Atherectomy System, Exchangeable Series, Stealth 360 Peripheral Orbital Atherectomy System (Nov 19, 2020)
- K200198: Wirion (Mar 18, 2020)

Source page: https://510kreport.com/company/cardiovascular-systems