Cardiovascular Systems Inc
FDA Regulatory Profile
Cardiovascular Systems Inc appears in FDA public data with 15 recalls — including 3 Class I (most serious) —, 26 510(k) clearances, 9 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-0394-2022, Class I) was initiated on November 22, 2021. Its most recent 510(k) clearance was granted on March 1, 2022.
Summary
- Total Recalls
- 15 (3 Class I)
- 510(k) Clearances
- 26
- Inspections
- 9
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-0394-2022 | Class I | WIRION EMBOLIC PROTECTION SYSTEM, Delivery Catheter and Filter and Retrieval Catheter, 6Fr, REF (Mod | November 22, 2021 |
| Z-2386-2021 | Class II | STEALTH 360 GEN2 PERIPHERAL ORBITAL ATHERECTOMY SYSTEM, 1.25MM MICRO, 145 CM, REF PRD-SC30-MICRO | July 21, 2021 |
| Z-2385-2021 | Class II | DIAMONDBACK 360 GEN2 PERIPHERAL ORBITAL ATHERECTOMY SYSTEM, 1.5MM SOLID, 145 CM, REF DBP-150SOLID145 | July 21, 2021 |
| Z-3021-2018 | Class II | CSI, Orbital Atherectomy System (OAS) Saline Infusion Pump, Rx only, Part Number: 7-10014, Model Nu | April 13, 2018 |
| Z-0506-2018 | Class II | Peripheral Diamondback 1.50 Solid OAD, a percutaneous orbital atherectomy system indicated for use a | September 14, 2017 |
| Z-0505-2018 | Class II | Peripheral Diamondback 1.25 Solid OAD, a percutaneous orbital atherectomy system indicated for use a | September 14, 2017 |
| Z-2122-2017 | Class II | CSI, Orbital Atherectomy System (OAS) Saline Infusion Pump, Rx only, Part Number: 7-10014, Model Nu | April 14, 2017 |
| Z-1771-2017 | Class II | ViperWire Advance Peripheral Guide Wire with Flex Tip, Model No. VPR-GW-FT18. Sterilized with Ethyl | March 3, 2017 |
| Z-1877-2017 | Class II | ViperWire Advance with Flextip Peripheral Atherectomy Guide Wire, Part Number: 7-10026-01,Model Numb | February 9, 2017 |
| Z-1230-2017 | Class II | DIAMONDBACK 360 Peripheral 1.50 Classic, Model DBP-150CLASS145 Peripheral Orbital Atherectomy Syste | December 7, 2016 |
| Z-2051-2016 | Class II | ViperWire Advance Peripheral Guide Wire, Sterilized with Ethylene Oxide, Rx Only. Part number 72023- | June 13, 2016 |
| Z-1290-2015 | Class I | Diamondback 360 Coronary Orbital Atherectomy System, Model Number: DBEC-125. The system is indica | March 4, 2015 |
| Z-2155-2014 | Class I | CSI Cardiovascular Systems, Inc., Diamondback 360 Peripheral Orbital Atherectomy System, Model Numbe | May 23, 2014 |
| Z-1095-2014 | Class III | CSI, Diamondback 360 Coronary Orbital Atherectomy System, Part Number 70058-02, Model Number DBEC-12 | January 27, 2014 |
| Z-1959-2012 | Class II | CSI Stealth 360-degree Orbital Atherectomy Device (OAD), Part Number 70056-11, Model Number PRD-SC30 | June 18, 2012 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K220109 | DIAMONDBACK 360 Peripheral Orbital Atherectomy System, DIAMONDBACK 360 Peripheral Orbital Atherectom | March 1, 2022 |
| K212725 | ViperCross Support Catheters | September 24, 2021 |
| K210586 | Diamonback 360 Peripheral Orbital Atherectomy System, Diamondback 360 Stealth Orbital Atherectomy sy | September 14, 2021 |
| K211240 | ViperCross Support Catheters | August 26, 2021 |
| K211251 | ViperCath XC Peripheral Exchange Catheter | May 26, 2021 |
| K210282 | WIRION Embolic Protection System | March 3, 2021 |
| K203008 | DIAMONDBACK 360 Peripheral Orbital Atherectomy System, DIAMONDBACK 360 Peripheral Orbital Atherectom | November 19, 2020 |
| K200198 | WIRION | March 18, 2020 |
| K190634 | Diamondback 360 Peripheral Orbital Atherectomy System, Stealth 360 Peripheral Orbital Atherectomy Sy | July 2, 2019 |
| K183000 | ViperCath XC Peripheral Exchange Catheter | December 29, 2018 |
| K182397 | Diamondback 360 Peripheral Orbital Atherectomy System Exchangeable Series | December 13, 2018 |
| K180416 | ViperWire Advance Guide Wire, Stealth 360 Orbital Peripheral Atherectomy Device (PAD), DIAMONDBACK 3 | April 17, 2018 |
| K170792 | Diamondback 360 Peripheral Orbital Atherectomy System | June 9, 2017 |
| K152694 | Diamondback 360 Peripheral Orbital Atherectomy System | October 21, 2015 |
| K150732 | Diamondback 360 Peripheral Orbital Atherectomy System | April 13, 2015 |
| K133999 | DIAMONDBACK 360 PERIPHERAL ORBITAL ATHERECTOMY SYSTEM | February 28, 2014 |
| K122987 | STEALTH 360 ORBITAL PAD SYSTEM | October 25, 2012 |
| K111388 | DIAMONDBACK 360* ORBITAL ATHERECTOMY SYSTEM, STEALTH 360* ORBITAL PAD SYSTEM | July 26, 2011 |
| K110389 | STEALTH 360 ORBITAL PAD SYSTEM | March 11, 2011 |
| K090521 | DIAMONDBACK 360 DBX | March 20, 2009 |