| auryon atherectomy catheter 1 5 mm xl hydrophilic coating exm-4010-h000 auryon atherectomy catheter 0 9 mm xl hydrophilic coating exm-4011-h000 auryon atherectomy catheter 1 5 mm xl exm -4010-0000 auryon atherectomy catheter 0 9 mm xl exm-4011-0000 | Eximo Medical | 510K | 2023 | 419 |
| auryon atherectomy catheter 1 7mm auryon atherectomy catheter 1 7mm hydrophilic coating | Eximo Medical | 510K | 2024 | 419 |
| modification to diamondback 360 degree orbital atherectomy system Evidence | Cardio Systems | 510K | 2008 | 19 |
| diamondback 360 orbital atherectomy system stealth 360 orbital pad system Evidence | Cardiovascular Systems | 510K | 2011 | 19 |
| diamondback 360 peripheral orbital atherectomy system Evidence | Cardiovascular Systems | 510K | 2015 | 19 |
| viperwire advance guide wire stealth 360 orbital peripheral atherectomy device pad diamondback 360 peripheral atherectomy system | Cardiovascular Systems | 510K | 2018 | 19 |
| diamondback 360 peripheral orbital atherectomy system exchangeable series Evidence | Cardiovascular Systems | 510K | 2018 | 19 |
| diamondback 360 peripheral orbital atherectomy system stealth 360 peripheral orbital atherectomy system Evidence | Cardiovascular Systems | 510K | 2019 | 19 |
| diamondback 360 degree orbital atherectomy system with viperslide lubricant Evidence | Cardiovascular Systems | 510K | 2008 | 19 |
| diamondback 360 degree orbital atherectomy system Evidence | Cardiovascular Systems | 510K | 2007 | 19 |
| diamondback 360 peripheral orbital atherectomy system diamondback 360 peripheral orbital atherectomy system exchangeable series stealth 360 peripheral orbital atherectomy system Evidence | Cardiovascular Systems | 510K | 2022 | 19 |
| diamondback 360 degree orbital atherectomy system Evidence | Cardiovascular Systems | 510K | 2007 | 19 |
| diamondback 360 peripheral orbital atherectomy system stealth 360 peripheral orbital atherectomy system diamondback 360 peripheral orbital atherectomy system exchangeable series Evidence | Cardiovascualr Systems | 510K | 2022 | 19 |
| diamondback 360 peripheral orbital atherectomy system Evidence | Cardiovascular Systems | 510K | 2013 | 19 |
| diamondback spinal system | Eminent Spine | 510K | 2010 | 19 |
| diamondback 360 dbx | Cardiovascular Systems | 510K | 2009 | 19 |
| diamondback 360 coronary orbital atherectomy device oad orbital atherectomy system pump oas pump viperwire advance c Evidence | Cardiovascular Systems | PMA | 2019 | 19 |
| diamondback 360 degree orbital atherectomy system for treatment of a-v shunt stenosis Evidence | Cardiovascular Systems | 510K | 2007 | 19 |
| diamonback 360 peripheral orbital atherectomy system diamondback 360 stealth orbital atherectomy system Evidence | Cardiovascular Systems | 510K | 2021 | 19 |
| diamondback 360 peripheral orbital atherectomy system diamondback 360 peripheral orbital atherectomy system exchangeable series stealth 360 peripheral orbital atherectomy system Evidence | Cardiovascular Systems | 510K | 2020 | 19 |
| viperwire advance guide wire diamondback 360 peripheral orbital atherectomy system stealth 360 orbital pad | Cardiovascular System | 510K | 2015 | 19 |
| modification to diamondback 360 orbital atherectomy system Evidence | Cardiovascular Systems | 510K | 2007 | 19 |
| diamondback 360 peripheral orbital atherectomy system Evidence | Cardiovascular Systems | 510K | 2017 | 19 |
| diamondback 360 peripheral orbital atherectomy system Evidence | Cardiovascular Systems | 510K | 2014 | 19 |
| diamondback 360 peripheral orbital atherectomy system Evidence | Cardiovascular Systems | 510K | 2015 | 19 |
| jetstream navitus l system jeystream navitus system jetstream g3 sf system jetstream sf 1 6 system | Medrad | 510K | 2012 | 18 |
| jetstream g3 system model pv31300 pv console model pvcn100 | Pathway Medical Technologies | 510K | 2010 | 18 |
| jetstream xc 2 4 3 4 system jetstream xc 2 1 3 0 system jetstream sc 1 85 system jetstream sc 1 6 system | Medrad | 510K | 2013 | 18 |
| jetstream pathway pv atherectomy system model pv10300 pvcn100 | Pathway Medical Technologies | 510K | 2008 | 18 |
| jetstream Evidence | Deldent | 510K | 2002 | 18 |
| jetstream g3 l system model pv31400 jetstream g3 l catheter with control pod pvcn100 pv console | Pathway Medical Technologies | 510K | 2010 | 18 |
| jetstream g3 se system jetstream g3 sf system model pv31230 jetstream g3 se catheter and control pod pvcn100 pv con | Pathway Medical Technologies | 510K | 2010 | 18 |
| jetstream g3 l system pv console models pv31400 pv31300 pvcn100 | Pathway Medical Technologies | 510K | 2010 | 18 |
| jetstream g2 system models pv20300 jetstream g2 catheter and control pod pvcn100 pv console | Pathway Medical Technologies | 510K | 2009 | 18 |
| jetstream cavity preparation system | Dove Systems | 510K | 1996 | 18 |
| jetstream g3 system model pv31300 jetstream g3 catheter and control pod pvcn100 pv console | Pathway Medical Technologies | 510K | 2009 | 18 |
| jetstream pathway pc atherectomy system model ov10300 | Pathway Medical Technologies | 510K | 2009 | 18 |
| ensphere tempo jetstream workspace cardiology module | Adac Laboratories | 510K | 2004 | 18 |
| jetstream navitus system jetstream g3 sf system jetstream g3 se system jetstream g3 l system | Pathway Medical Technologies | 510K | 2011 | 18 |
| jetstream g2 nxt system model pv20300 | Pathway Medical Technologies | 510K | 2009 | 18 |
| jetstream xc 2 4 3 4 jetstream xc 2 1 3 0 jetstream sc 1 85 jetstream sc 1 6 | Medrad | 510K | 2014 | 18 |
| jetstream g3 r sf 1 6 system | Pathway Medical Technologies | 510K | 2011 | 18 |
| jetstream workspace | Adac Laboratories | 510K | 2004 | 18 |
| jetstream navitus l system | Pathway Medical Technologies | 510K | 2012 | 18 |
| jetstream g2 system models pv20300 jetstream g2 catheter and control pod pvcn100 pv console | Pathway Medical Technologies | 510K | 2009 | 18 |
| jetstream g3 system | Pathway Medical Technologies | 510K | 2009 | 18 |
| jetstream workspace | Adac Laboratories | 510K | 2006 | 18 |
| 1 8mm x 149cm phoenix atherectomy system 2 2mm x 149cm phoenix atherectomy system 2 4mm x 130cm phoenix atherectomy system | Volcano Atheromed | 510K | 2017 | 8 |
| phoenix 5f tracking atherectomy catheter phoenix 6f tracking atherectomy catheter phoenix 7d deflecting atherectomy ca | Atheromed | 510K | 2014 | 8 |
| 1 8mm x 149 cm phoenix atherectomy catheter 2 2mm x 149 cm phoenix atherectomy catheter phoenix handle phoenix wire support clip Evidence | Volcano Atheromed | 510K | 2014 | 8 |