| Auryon Atherectomy System (K260244) | Eximo Medical | 2026-04-10 |
| FreedomFlow™ Orbital Circumferential Atherectomy System (H6005/ 4Fr 3-Sphere Configuration) (K250723) | Cardio Flow Inc., | 2025-04-25 |
| Turbo-Elite Laser Atherectomy Catheter (K250385) | Spectranetics | 2025-03-13 |
| Rotarex Atherectomy System (K242757) | Bard Peripheral Vascular, Inc. | 2025-01-30 |
| FreedomFlow™ Orbital Circumferential Atherectomy System (K242947) | Cardio Flow Inc., | 2024-11-05 |
| Auryon Atherectomy Catheter 1.7mm; Auryon Atherectomy Catheter 1.7mm, Hydrophilic Coating (K241553) | Eximo Medical, Ltd. | 2024-06-27 |
| FreedomFlow Orbital Circumferential Atherectomy System (H6004/5Fr 3-Sphere Configuration) (K233483) | Cardio Flow Inc., | 2024-02-15 |
| 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) (K233668) | Eximo Medical, Ltd. | 2023-12-15 |
| FreedomFlow Orbital Circumferential Atherectomy System (K231538) | Cardio Flow Inc., | 2023-09-27 |
| Auryon Atherectomy System (K230709) | Eximo Medical, Ltd. | 2023-06-09 |
| Pantheris LV Atherectomy Catheter (K230005) | Avinger, Inc. | 2023-06-06 |
| Turbo-Power (2.0mm) Laser Atherectomy Catheters, Turbo-Power (2.3mm) Laser Atherectomy Catheters (K222837) | Spectranetics, Inc. | 2022-12-08 |
| Auryon Atherectomy Catheters (K220116) | Eximo Medical, Ltd. | 2022-09-26 |
| ROTAPRO Rotational Atherectomy System (K220962) | Boston Scientific Corporation | 2022-09-06 |
| Auryon Atherectomy System (K221077) | Eximo Medical, Ltd. | 2022-06-09 |
| Diamondback 360 Peripheral Orbital Atherectomy System, Stealth 360 Peripheral Orbital Atherectomy System, Diamondback 360 Peripheral Orbital Atherectomy System Exchangeable Series (K220568) | Cardiovascualr Systems, Inc. | 2022-04-27 |
| DIAMONDBACK 360 Peripheral Orbital Atherectomy System, DIAMONDBACK 360 Peripheral Orbital Atherectomy System, Exchangeable Series, Stealth 360 Peripheral Orbital Atherectomy System (K220109) | Cardiovascular Systems, Inc. | 2022-03-01 |
| Revolution Peripheral Atherectomy System (K212351) | Rex Medical, L.P. | 2021-12-15 |
| Pantheris System (K212047) | Avinger, Inc. | 2021-11-16 |
| Rotarex Atherectomy System (K211738) | C.R. Bard, Inc. | 2021-09-14 |
| Diamonback 360 Peripheral Orbital Atherectomy System, Diamondback 360 Stealth Orbital Atherectomy system (K210586) | Cardiovascular Systems, Inc. | 2021-09-14 |
| TurboHawk Plus Directional Atherectomy System (K212027) | Medtronic, Inc. | 2021-08-24 |
| 2.4mm X 130cm Phoenix Deflecting Atherectomy System, 1.5mm X 149cm Phoenix Atherectomy System (K211518) | Volcano Atheromed, Inc. | 2021-06-14 |
| Auryon Atherectomy System (K202835) | Eximo Medical, Ltd. | 2020-12-02 |
| DIAMONDBACK 360 Peripheral Orbital Atherectomy System, DIAMONDBACK 360 Peripheral Orbital Atherectomy System, Exchangeable Series, Stealth 360 Peripheral Orbital Atherectomy System (K203008) | Cardiovascular Systems, Inc. | 2020-11-19 |
| Revolution Peripheral Atherectomy System, Revolution Peripheral Atherectomy Guidewire (K191419) | Rex Medical, L.P. | 2019-09-12 |
| Diamondback 360 Peripheral Orbital Atherectomy System, Stealth 360 Peripheral Orbital Atherectomy System (K190634) | Cardiovascular Systems, Inc. | 2019-07-02 |
| Pantheris SV (K182341) | Avinger, Inc. | 2019-04-09 |
| Phoenix Atherectomy System (K182972) | Volcano Atheromed, Inc. | 2018-12-20 |
| Phoenix 2.4mm Atherectomy Plus System (K181877) | Volcano Atheromed, Inc. | 2018-12-17 |
| Diamondback 360 Peripheral Orbital Atherectomy System Exchangeable Series (K182397) | Cardiovascular Systems, Inc. | 2018-12-13 |
| B-Laser Atherectomy System (K181642) | Eximo Medical, Ltd. | 2018-10-05 |
| Pantheris System (K173862) | Avinger, Inc. | 2018-05-22 |
| ViperWire Advance Guide Wire, Stealth 360 Orbital Peripheral Atherectomy Device (PAD), DIAMONDBACK 360 Peripheral Atherectomy System (K180416) | Cardiovascular Systems, Inc. | 2018-04-17 |
| Straub Endovascular System (K172315) | Straub Medical AG | 2018-04-12 |
| Turbo-Power (2.0mm) Laser Atherectomy Catheters, Turbo-Power (2.3mm) Laser Atherectomy Catheters (K180694) | Spectranetics, Inc. | 2018-04-05 |
| Turbo-Power (2.0mm) Laser Atherectomy Catheters, Turbo-Power (2.3mm) Laser Atherectomy Catheters (K172687) | Spectranetics, Inc. | 2017-11-27 |
| Pantheris Catheter (8F), Pantheris Catheter (7F), Lightbox HS Imaging Console, Lightbox Sled (K172236) | Avinger, Inc. | 2017-10-30 |
| 1.8mm X 149cm Phoenix Atherectomy System, 2.2mm X 149cm Phoenix Atherectomy System, 2.4mm X 130cm Phoenix Atherectomy System (K172386) | Volcano Atheromed, Inc. | 2017-08-24 |
| SilverHawk Peripheral Plaque Excision System, TurboHawk Peripheral Plaque Excision System (K170191) | Medtronic Vascular, Inc. | 2017-06-16 |
| Diamondback 360 Peripheral Orbital Atherectomy System (K170792) | Cardiovascular Systems, Inc. | 2017-06-09 |
| Spectranetics Turbo-Elite Laser Atherectomy Catheters (K170059) | Spectranetics, Inc. | 2017-04-07 |
| Turbo-Power (2.0mm) Laser Atherectomy Catheters (K162561) | Spectranetics, Inc. | 2017-01-05 |
| Pantheris Catheter (8F); Pantheris Cather (7F); Lightbox HS Imaging Console; Lightbox Sled (K163264) | Avinger, Inc. | 2016-12-21 |
| Pantheris Catheter, Lightbix HS Imaging Console, Lightbox Sled (K162326) | Avinger, Inc. | 2016-10-18 |
| HawkOne Directional Atherectomy System (K161361) | Medtronic Vascular, Inc. | 2016-10-14 |
| Pantheris Catheter (K160827) | Avinger, Inc. | 2016-04-21 |
| Pantheris Catheter (8Fr), Pantheris Catheter (7Fr) (K153460) | Avinger, Inc. | 2016-03-01 |
| Turbo-Power Laser Atherectomy Catheter (K152181) | Spectranetics, Inc. | 2015-11-12 |
| Diamondback 360 Peripheral Orbital Atherectomy System (K152694) | Cardiovascular Systems, Inc. | 2015-10-21 |
| Pantheris System (K152275) | Avinger, Inc. | 2015-10-14 |
| ViperWire Advance Guide Wire, Diamondback 360 Peripheral Orbital Atherectomy System, Stealth 360 Orbital PAD (K151260) | Cardiovascular System, Inc. | 2015-06-10 |
| 2.4mm X 127 cm Phoenix Atherectomy Deflecting System (K151145) | Volcano Atheromed, Inc. | 2015-05-26 |
| Diamondback 360 Peripheral Orbital Atherectomy System (K150732) | Cardiovascular Systems, Inc. | 2015-04-13 |
| 1.8mm X 149 cm Phoenix Atherectomy Catheter, 2.2mm X 149 cm Phoenix Atherectomy Catheter, Phoenix Handle, Phoenix Wire Support Clip (K143328) | Volcano Atheromed, Inc. | 2014-12-19 |
| HAWKONE DIRECTIONAL ATHERECTOMY SYSTEM (K141801) | Covidien, LLC | 2014-10-16 |
| JETSTREAM XC 2.4/3.4; JETSTREAM XC 2.1/3.0; JETSTREAM SC 1.85; JETSTREAM SC 1.6 (K133023) | Medrad, Inc. | 2014-08-27 |
| 1.8 MM PHOENIX ATHERECTOMY CATHETER, 2.2 MM PHOENIX ATHERECTOMY CATHETER, PHOENIX HANDLE, PHOENIX WIRE SUPPORT CLIP (K140944) | Atheromed, Inc. | 2014-08-22 |
| TURBO-ELITE ATHERECTOMY CATHETERS, TURBO TANDEM SYSTEM (K140775) | Spectranetics Corporation | 2014-07-23 |
| DIAMONDBACK 360 PERIPHERAL ORBITAL ATHERECTOMY SYSTEM (K133999) | Cardiovascular Systems, Inc. | 2014-02-28 |
| PHOENIX 5F TRACKING ATHERECTOMY CATHETER, PHOENIX 6F TRACKING ATHERECTOMY CATHETER, PHOENIX 7D DEFLECTING ATHERECTOMY CA (K132682) | Atheromed, Inc. | 2014-01-17 |
| ROTABLATOR ROTATIONAL ATHERECTOMY SYSTEM WITH THE PERIPHERAL ROTALINK PLUS (K133566) | Boston Scientific Corp | 2013-12-20 |
| DIAMONDBACK 360 PERIPHERAL ORBITAL ATHERECTOMY SYSTEM (K133399) | Cardiovascular Systems Incorporated | 2013-11-22 |
| STEALTH 360 ORBITAL PAD SYSTEM (K131092) | Cardio Systems, Inc. | 2013-06-24 |
| JETSTREAM XC 2.4/3.4 SYSTEM; JETSTREAM XC 2.1/3.0 SYSTEM; JETSTREAM SC 1.85 SYSTEM; JETSTREAM SC 1.6 SYSTEM (K130637) | Medrad, Inc. | 2013-04-10 |
| 2.5MM TURBO ELITE 035, 2.3MM TURBO ELITE 035 (K123632) | Spectranetics Corp. | 2013-01-25 |
| STEALTH 360 ORBITAL PAD SYSTEM (K122987) | Cardiovascular Systems, Inc. | 2012-10-25 |
| JETSTREAM NAVITUS L SYSTEM JEYSTREAM NAVITUS SYSTEM JETSTREAM G3 SF SYSTEM JETSTREAM SF 1.6 SYSTEM (K122916) | Medrad, Inc. | 2012-10-19 |
| ROTABLATOR ROTATIONAL ATHERECTOMY SYSTEM WITH PERIPHERAL ROTALINK PLUS (K121774) | Boston Scientific Corp | 2012-09-13 |
| CLEANER ROTATIONAL THROMBECTOMY SYSTEM (K120346) | Rex Medical | 2012-06-01 |
| JETSTREAM NAVITUS L SYSTEM (K120242) | Pathway Medical Technologies, Inc. | 2012-02-24 |
| TURBOHAWK PERIPHERAL PLAQUE EXCISION SYSTEM (K111723) | Ev3, Inc. | 2011-10-27 |
| DIAMONDBACK 360* ORBITAL ATHERECTOMY SYSTEM, STEALTH 360* ORBITAL PAD SYSTEM (K111388) | Cardiovascular Systems, Inc. | 2011-07-26 |
| JETSTREAM G3 (R) SF 1.6 SYSTEM (K111229) | Pathway Medical Technologies, Inc. | 2011-06-01 |
| JETSTREAM NAVITUS SYSTEM; JETSTREAM G3 SF SYSTEM; JETSTREAM G3 SE SYSTEM; JETSTREAM G3 L SYSTEM (K110626) | Pathway Medical Technologies, Inc. | 2011-04-20 |
| STEALTH 360 ORBITAL PAD SYSTEM (K110389) | Cardiovascular Systems, Inc. | 2011-03-11 |
| TURBOHAWK PEROPHERAL PLAQUE EXCISION SYSTEM (K103618) | Ev3, Inc. | 2011-01-05 |
| JETSTREAM G3 SE SYSTEM, JETSTREAM G3 SF SYSTEM MODEL PV31230 (JETSTREAM G3 SE CATHETER AND CONTROL POD); PVCN100 (PV CON (K101334) | Pathway Medical Technologies, Inc. | 2010-06-11 |
| JETSTREAM G3 SYSTEM, MODEL PV31300, PV CONSOLE, MODEL PVCN100 (K101221) | Pathway Medical Technologies, Inc. | 2010-06-02 |
| JETSTREAM G3 L SYSTEM, PV CONSOLE, MODELS PV31400, PV31300, PVCN100 (K100462) | Pathway Medical Technologies, Inc. | 2010-05-19 |
| CLEANER ROTATIONAL THROMBECTOMY SYSTEM (9 MM X 65 CM) AND (9 MM X 120 CM) (K091029) | Rex Medical | 2010-02-18 |
| TURBO-TANDEM SYSTEM MODEL 472-110 (K094036) | Spectranetics Corp. | 2010-01-25 |
| JETSTREAM G3 L SYSTEM MODEL PV31400 (JETSTREAM G3 L CATHETER WITH CONTROL POD); PVCN100 (PV CONSOLE) (K093918) | Pathway Medical Technologies, Inc. | 2010-01-21 |
| JETSTREAM G3 SYSTEM (K093456) | Pathway Medical Technologies, Inc. | 2009-12-01 |
| TURBOHAWK PERIPHERAL PLAQUE EXCISION SYSTEM (K093301) | Ev3, Inc. | 2009-11-06 |
| JETSTREAM G3 SYSTEM, MODEL PV31300 ( JETSTREAM G3 CATHETER AND CONTROL POD)., PVCN100 (PV CONSOLE) (K092332) | Pathway Medical Technologies, Inc. | 2009-09-03 |
| JETSTREAM G2 NXT SYSTEM, MODEL PV20300 (K091509) | Pathway Medical Technologies, Inc. | 2009-06-19 |
| DIAMONDBACK 360 DBX (K090521) | Cardiovascular Systems, Inc. | 2009-03-20 |
| JETSTREAM G2 SYSTEM, MODELS PV20300 (JETSTREAM G2 CATHETER AND CONTROL POD); PVCN100 (PV CONSOLE) (K090325) | Pathway Medical Technologies, Inc. | 2009-03-11 |
| JETSTREAM PATHWAY PC ATHERECTOMY SYSTEM, MODEL OV10300 (K083489) | Pathway Medical Technologies, Inc. | 2009-01-23 |
| JETSTREAM G2 SYSTEM, MODELS PV20300 (JETSTREAM G2 CATHETER AND CONTROL POD); PVCN100 (PV CONSOLE) (K083837) | Pathway Medical Technologies, Inc. | 2009-01-13 |
| DIAMONDBACK 360 DEGREE ORBITAL ATHERECTOMY SYSTEM WITH VIPERSLIDE LUBRICANT (K082981) | Cardiovascular Systems, Inc. | 2008-10-31 |
| JETSTREAM PATHWAY PV ATHERECTOMY SYSTEM, MODEL PV10300, PVCN100 (K082664) | Pathway Medical Technologies, Inc. | 2008-10-06 |
| MODIFICATION TO PATHWAY PV ATHERECTOMY SYSTEM (K082186) | Pathway Medical Technologies, Inc. | 2008-08-29 |
| MODIFICATION TO DIAMONDBACK 360 DEGREE ORBITAL ATHERECTOMY SYSTEM (K081944) | Cardio Systems, Inc. | 2008-08-14 |
| PATHWAY PV ATHERECTOMY SYSTEM (K081328) | Pathway Medical Technologies, Inc. | 2008-07-17 |
| SILVERHAWK-R PERIPHERAL PLAQUE EXCISION SYSTEM FOR SURGICAL USE (K071432) | Fox Hollow Technologies | 2008-02-12 |
| MODIFICATION TO: DIAMONDBACK 360 ORBITAL ATHERECTOMY SYSTEM (K072748) | Cardiovascular Systems, Inc. | 2007-11-09 |
| DIAMONDBACK 360 DEGREE ORBITAL ATHERECTOMY SYSTEM (K072800) | Cardiovascular Systems, Inc. | 2007-10-25 |
| DIAMONDBACK 360 DEGREE ORBITAL ATHERECTOMY SYSTEM FOR TREATMENT OF A-V SHUNT STENOSIS (K071427) | Cardiovascular Systems, Inc. | 2007-08-30 |