| Z-0394-2022 | Class I | WIRION EMBOLIC PROTECTION SYSTEM, Delivery Catheter and Filter and Retrieval Catheter, 6Fr, REF (Mod | November 22, 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-2386-2021 | Class II | STEALTH 360 GEN2 PERIPHERAL ORBITAL ATHERECTOMY SYSTEM, 1.25MM MICRO, 145 CM, REF PRD-SC30-MICRO | 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 |