FDA Product Code
FDA Product Code MCW — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Cardiovascular
- 21 CFR Citation
- 870.4875
510(k) Clearances — 146 records · page 1 of 2
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K260244 | Auryon Atherectomy System | Eximo Medical | 2026-04-10 | Traditional | PDF ↗ |
| K250723 | FreedomFlow Orbital Circumferential Atherectomy System (H6005/ 4Fr 3-Sphere Configuration) | Cardio Flow Inc., | 2025-04-25 | Special | PDF ↗ |
| K250385 | Turbo-Elite Laser Atherectomy Catheter | Spectranetics | 2025-03-13 | Special | PDF ↗ |
| K242757 | Rotarex Atherectomy System | Bard Peripheral Vascular, Inc. | 2025-01-30 | Special | PDF ↗ |
| K242947 | FreedomFlow Orbital Circumferential Atherectomy System | Cardio Flow Inc., | 2024-11-05 | Special | PDF ↗ |
| K241553 | Auryon Atherectomy Catheter 1.7mm; Auryon Atherectomy Catheter 1.7mm, Hydrophilic Coating | Eximo Medical, Ltd. | 2024-06-27 | Special | PDF ↗ |
| K233483 | FreedomFlow Orbital Circumferential Atherectomy System (H6004/5Fr 3-Sphere Configuration) | Cardio Flow Inc., | 2024-02-15 | Special | PDF ↗ |
| K233668 | 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, Ltd. | 2023-12-15 | Special | PDF ↗ |
| K231538 | FreedomFlow Orbital Circumferential Atherectomy System | Cardio Flow Inc., | 2023-09-27 | Traditional | PDF ↗ |
| K230709 | Auryon Atherectomy System | Eximo Medical, Ltd. | 2023-06-09 | Special | PDF ↗ |
| K230005 | Pantheris LV Atherectomy Catheter | Avinger, Inc. | 2023-06-06 | Traditional | PDF ↗ |
| K222837 | Turbo-Power (2.0mm) Laser Atherectomy Catheters, Turbo-Power (2.3mm) Laser Atherectomy Catheters | Spectranetics, Inc. | 2022-12-08 | Special | PDF ↗ |
| K220116 | Auryon Atherectomy Catheters | Eximo Medical, Ltd. | 2022-09-26 | Traditional | PDF ↗ |
| K220962 | ROTAPRO Rotational Atherectomy System | Boston Scientific Corporation | 2022-09-06 | Traditional | PDF ↗ |
| K221077 | Auryon Atherectomy System | Eximo Medical, Ltd. | 2022-06-09 | Traditional | PDF ↗ |
| K220568 | Diamondback 360 Peripheral Orbital Atherectomy System, Stealth 360 Peripheral Orbital Atherectomy System, Diamondback 360 Peripheral Orbital Atherectomy System Exchangeable Series | Cardiovascualr Systems, Inc. | 2022-04-27 | Traditional | PDF ↗ |
| K220109 | DIAMONDBACK 360 Peripheral Orbital Atherectomy System, DIAMONDBACK 360 Peripheral Orbital Atherectomy System, Exchangeable Series, Stealth 360 Peripheral Orbital Atherectomy System | Cardiovascular Systems, Inc. | 2022-03-01 | Special | PDF ↗ |
| K212351 | Revolution Peripheral Atherectomy System | Rex Medical, L.P. | 2021-12-15 | Traditional | PDF ↗ |
| K212047 | Pantheris System | Avinger, Inc. | 2021-11-16 | Traditional | PDF ↗ |
| K211738 | Rotarex Atherectomy System | C.R. Bard, Inc. | 2021-09-14 | Traditional | PDF ↗ |
| K210586 | Diamonback 360 Peripheral Orbital Atherectomy System, Diamondback 360 Stealth Orbital Atherectomy system | Cardiovascular Systems, Inc. | 2021-09-14 | Special | PDF ↗ |
| K212027 | TurboHawk Plus Directional Atherectomy System | Medtronic, Inc. | 2021-08-24 | Traditional | PDF ↗ |
| K211518 | 2.4mm X 130cm Phoenix Deflecting Atherectomy System, 1.5mm X 149cm Phoenix Atherectomy System | Volcano Atheromed, Inc. | 2021-06-14 | Special | PDF ↗ |
| K202835 | Auryon Atherectomy System | Eximo Medical, Ltd. | 2020-12-02 | Special | PDF ↗ |
| K203008 | DIAMONDBACK 360 Peripheral Orbital Atherectomy System, DIAMONDBACK 360 Peripheral Orbital Atherectomy System, Exchangeable Series, Stealth 360 Peripheral Orbital Atherectomy System | Cardiovascular Systems, Inc. | 2020-11-19 | Traditional | PDF ↗ |
| K191419 | Revolution Peripheral Atherectomy System, Revolution Peripheral Atherectomy Guidewire | Rex Medical, L.P. | 2019-09-12 | Traditional | PDF ↗ |
| K190634 | Diamondback 360 Peripheral Orbital Atherectomy System, Stealth 360 Peripheral Orbital Atherectomy System | Cardiovascular Systems, Inc. | 2019-07-02 | Traditional | PDF ↗ |
| K182341 | Pantheris SV | Avinger, Inc. | 2019-04-09 | Traditional | PDF ↗ |
| K182972 | Phoenix Atherectomy System | Volcano Atheromed, Inc. | 2018-12-20 | Special | PDF ↗ |
| K181877 | Phoenix 2.4mm Atherectomy Plus System | Volcano Atheromed, Inc. | 2018-12-17 | Traditional | PDF ↗ |
| K182397 | Diamondback 360 Peripheral Orbital Atherectomy System Exchangeable Series | Cardiovascular Systems, Inc. | 2018-12-13 | Traditional | PDF ↗ |
| K181642 | B-Laser Atherectomy System | Eximo Medical, Ltd. | 2018-10-05 | Traditional | PDF ↗ |
| K173862 | Pantheris System | Avinger, Inc. | 2018-05-22 | Traditional | PDF ↗ |
| K180416 | ViperWire Advance Guide Wire, Stealth 360 Orbital Peripheral Atherectomy Device (PAD), DIAMONDBACK 360 Peripheral Atherectomy System | Cardiovascular Systems, Inc. | 2018-04-17 | Traditional | PDF ↗ |
| K172315 | Straub Endovascular System | Straub Medical AG | 2018-04-12 | Traditional | PDF ↗ |
| K180694 | Turbo-Power (2.0mm) Laser Atherectomy Catheters, Turbo-Power (2.3mm) Laser Atherectomy Catheters | Spectranetics, Inc. | 2018-04-05 | Special | PDF ↗ |
| K172687 | Turbo-Power (2.0mm) Laser Atherectomy Catheters, Turbo-Power (2.3mm) Laser Atherectomy Catheters | Spectranetics, Inc. | 2017-11-27 | Traditional | PDF ↗ |
| K172236 | Pantheris Catheter (8F), Pantheris Catheter (7F), Lightbox HS Imaging Console, Lightbox Sled | Avinger, Inc. | 2017-10-30 | Special | PDF ↗ |
| K172386 | 1.8mm X 149cm Phoenix Atherectomy System, 2.2mm X 149cm Phoenix Atherectomy System, 2.4mm X 130cm Phoenix Atherectomy System | Volcano Atheromed, Inc. | 2017-08-24 | Special | PDF ↗ |
| K170191 | SilverHawk Peripheral Plaque Excision System, TurboHawk Peripheral Plaque Excision System | Medtronic Vascular, Inc. | 2017-06-16 | Special | PDF ↗ |
| K170792 | Diamondback 360 Peripheral Orbital Atherectomy System | Cardiovascular Systems, Inc. | 2017-06-09 | Special | PDF ↗ |
| K170059 | Spectranetics Turbo-Elite Laser Atherectomy Catheters | Spectranetics, Inc. | 2017-04-07 | Traditional | PDF ↗ |
| K162561 | Turbo-Power (2.0mm) Laser Atherectomy Catheters | Spectranetics, Inc. | 2017-01-05 | Traditional | PDF ↗ |
| K163264 | Pantheris Catheter (8F); Pantheris Cather (7F); Lightbox HS Imaging Console; Lightbox Sled | Avinger, Inc. | 2016-12-21 | Special | PDF ↗ |
| K162326 | Pantheris Catheter, Lightbix HS Imaging Console, Lightbox Sled | Avinger, Inc. | 2016-10-18 | Traditional | PDF ↗ |
| K161361 | HawkOne Directional Atherectomy System | Medtronic Vascular, Inc. | 2016-10-14 | Traditional | PDF ↗ |
| K160827 | Pantheris Catheter | Avinger, Inc. | 2016-04-21 | Special | PDF ↗ |
| K153460 | Pantheris Catheter (8Fr), Pantheris Catheter (7Fr) | Avinger, Inc. | 2016-03-01 | Traditional | PDF ↗ |
| K152181 | Turbo-Power Laser Atherectomy Catheter | Spectranetics, Inc. | 2015-11-12 | Traditional | PDF ↗ |
| K152694 | Diamondback 360 Peripheral Orbital Atherectomy System | Cardiovascular Systems, Inc. | 2015-10-21 | Special | PDF ↗ |
| K152275 | Pantheris System | Avinger, Inc. | 2015-10-14 | Traditional | PDF ↗ |
| K151260 | ViperWire Advance Guide Wire, Diamondback 360 Peripheral Orbital Atherectomy System, Stealth 360 Orbital PAD | Cardiovascular System, Inc. | 2015-06-10 | Special | PDF ↗ |
| K151145 | 2.4mm X 127 cm Phoenix Atherectomy Deflecting System | Volcano Atheromed, Inc. | 2015-05-26 | Special | PDF ↗ |
| K150732 | Diamondback 360 Peripheral Orbital Atherectomy System | Cardiovascular Systems, Inc. | 2015-04-13 | Special | PDF ↗ |
| K143328 | 1.8mm X 149 cm Phoenix Atherectomy Catheter, 2.2mm X 149 cm Phoenix Atherectomy Catheter, Phoenix Handle, Phoenix Wire Support Clip | Volcano Atheromed, Inc. | 2014-12-19 | Special | PDF ↗ |
| K141801 | HAWKONE DIRECTIONAL ATHERECTOMY SYSTEM | Covidien, LLC | 2014-10-16 | Traditional | PDF ↗ |
| K133023 | JETSTREAM XC 2.4/3.4; JETSTREAM XC 2.1/3.0; JETSTREAM SC 1.85; JETSTREAM SC 1.6 | Medrad, Inc. | 2014-08-27 | Traditional | PDF ↗ |
| K140944 | 1.8 MM PHOENIX ATHERECTOMY CATHETER, 2.2 MM PHOENIX ATHERECTOMY CATHETER, PHOENIX HANDLE, PHOENIX WIRE SUPPORT CLIP | Atheromed, Inc. | 2014-08-22 | Special | PDF ↗ |
| K140775 | TURBO-ELITE ATHERECTOMY CATHETERS, TURBO TANDEM SYSTEM | Spectranetics Corporation | 2014-07-23 | Traditional | PDF ↗ |
| K133999 | DIAMONDBACK 360 PERIPHERAL ORBITAL ATHERECTOMY SYSTEM | Cardiovascular Systems, Inc. | 2014-02-28 | Special | PDF ↗ |
| K132682 | PHOENIX 5F TRACKING ATHERECTOMY CATHETER, PHOENIX 6F TRACKING ATHERECTOMY CATHETER, PHOENIX 7D DEFLECTING ATHERECTOMY CA | Atheromed, Inc. | 2014-01-17 | Traditional | PDF ↗ |
| K133566 | ROTABLATOR ROTATIONAL ATHERECTOMY SYSTEM WITH THE PERIPHERAL ROTALINK PLUS | Boston Scientific Corp | 2013-12-20 | Special | PDF ↗ |
| K133399 | DIAMONDBACK 360 PERIPHERAL ORBITAL ATHERECTOMY SYSTEM | Cardiovascular Systems Incorporated | 2013-11-22 | Special | PDF ↗ |
| K131092 | STEALTH 360 ORBITAL PAD SYSTEM | Cardio Systems, Inc. | 2013-06-24 | Special | PDF ↗ |
| K130637 | 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, Inc. | 2013-04-10 | Special | PDF ↗ |
| K123632 | 2.5MM TURBO ELITE 035, 2.3MM TURBO ELITE 035 | Spectranetics Corp. | 2013-01-25 | Traditional | PDF ↗ |
| K122987 | STEALTH 360 ORBITAL PAD SYSTEM | Cardiovascular Systems, Inc. | 2012-10-25 | Special | PDF ↗ |
| K122916 | JETSTREAM NAVITUS L SYSTEM JEYSTREAM NAVITUS SYSTEM JETSTREAM G3 SF SYSTEM JETSTREAM SF 1.6 SYSTEM | Medrad, Inc. | 2012-10-19 | Special | PDF ↗ |
| K121774 | ROTABLATOR ROTATIONAL ATHERECTOMY SYSTEM WITH PERIPHERAL ROTALINK PLUS | Boston Scientific Corp | 2012-09-13 | Traditional | PDF ↗ |
| K120346 | CLEANER ROTATIONAL THROMBECTOMY SYSTEM | Rex Medical | 2012-06-01 | Traditional | PDF ↗ |
| K120242 | JETSTREAM NAVITUS L SYSTEM | Pathway Medical Technologies, Inc. | 2012-02-24 | Special | PDF ↗ |
| K111723 | TURBOHAWK PERIPHERAL PLAQUE EXCISION SYSTEM | Ev3, Inc. | 2011-10-27 | Traditional | PDF ↗ |
| K111388 | DIAMONDBACK 360* ORBITAL ATHERECTOMY SYSTEM, STEALTH 360* ORBITAL PAD SYSTEM | Cardiovascular Systems, Inc. | 2011-07-26 | Traditional | PDF ↗ |
| K111229 | JETSTREAM G3 (R) SF 1.6 SYSTEM | Pathway Medical Technologies, Inc. | 2011-06-01 | Special | PDF ↗ |
| K110626 | JETSTREAM NAVITUS SYSTEM; JETSTREAM G3 SF SYSTEM; JETSTREAM G3 SE SYSTEM; JETSTREAM G3 L SYSTEM | Pathway Medical Technologies, Inc. | 2011-04-20 | Special | PDF ↗ |
| K110389 | STEALTH 360 ORBITAL PAD SYSTEM | Cardiovascular Systems, Inc. | 2011-03-11 | Special | PDF ↗ |
| K103618 | TURBOHAWK PEROPHERAL PLAQUE EXCISION SYSTEM | Ev3, Inc. | 2011-01-05 | Traditional | PDF ↗ |
| K101334 | JETSTREAM G3 SE SYSTEM, JETSTREAM G3 SF SYSTEM MODEL PV31230 (JETSTREAM G3 SE CATHETER AND CONTROL POD); PVCN100 (PV CON | Pathway Medical Technologies, Inc. | 2010-06-11 | Special | PDF ↗ |
| K101221 | JETSTREAM G3 SYSTEM, MODEL PV31300, PV CONSOLE, MODEL PVCN100 | Pathway Medical Technologies, Inc. | 2010-06-02 | Special | PDF ↗ |
| K100462 | JETSTREAM G3 L SYSTEM, PV CONSOLE, MODELS PV31400, PV31300, PVCN100 | Pathway Medical Technologies, Inc. | 2010-05-19 | Traditional | PDF ↗ |
| K091029 | CLEANER ROTATIONAL THROMBECTOMY SYSTEM (9 MM X 65 CM) AND (9 MM X 120 CM) | Rex Medical | 2010-02-18 | Traditional | PDF ↗ |
| K094036 | TURBO-TANDEM SYSTEM MODEL 472-110 | Spectranetics Corp. | 2010-01-25 | Special | PDF ↗ |
| K093918 | JETSTREAM G3 L SYSTEM MODEL PV31400 (JETSTREAM G3 L CATHETER WITH CONTROL POD); PVCN100 (PV CONSOLE) | Pathway Medical Technologies, Inc. | 2010-01-21 | Special | PDF ↗ |
| K093456 | JETSTREAM G3 SYSTEM | Pathway Medical Technologies, Inc. | 2009-12-01 | Special | PDF ↗ |
| K093301 | TURBOHAWK PERIPHERAL PLAQUE EXCISION SYSTEM | Ev3, Inc. | 2009-11-06 | Traditional | PDF ↗ |
| K092332 | JETSTREAM G3 SYSTEM, MODEL PV31300 ( JETSTREAM G3 CATHETER AND CONTROL POD)., PVCN100 (PV CONSOLE) | Pathway Medical Technologies, Inc. | 2009-09-03 | Special | PDF ↗ |
| K091509 | JETSTREAM G2 NXT SYSTEM, MODEL PV20300 | Pathway Medical Technologies, Inc. | 2009-06-19 | Special | PDF ↗ |
| K090521 | DIAMONDBACK 360 DBX | Cardiovascular Systems, Inc. | 2009-03-20 | Special | PDF ↗ |
| K090325 | JETSTREAM G2 SYSTEM, MODELS PV20300 (JETSTREAM G2 CATHETER AND CONTROL POD); PVCN100 (PV CONSOLE) | Pathway Medical Technologies, Inc. | 2009-03-11 | Special | PDF ↗ |
| K083489 | JETSTREAM PATHWAY PC ATHERECTOMY SYSTEM, MODEL OV10300 | Pathway Medical Technologies, Inc. | 2009-01-23 | Traditional | PDF ↗ |
| K083837 | JETSTREAM G2 SYSTEM, MODELS PV20300 (JETSTREAM G2 CATHETER AND CONTROL POD); PVCN100 (PV CONSOLE) | Pathway Medical Technologies, Inc. | 2009-01-13 | Special | PDF ↗ |
| K082981 | DIAMONDBACK 360 DEGREE ORBITAL ATHERECTOMY SYSTEM WITH VIPERSLIDE LUBRICANT | Cardiovascular Systems, Inc. | 2008-10-31 | Special | PDF ↗ |
| K082664 | JETSTREAM PATHWAY PV ATHERECTOMY SYSTEM, MODEL PV10300, PVCN100 | Pathway Medical Technologies, Inc. | 2008-10-06 | Special | PDF ↗ |
| K082186 | MODIFICATION TO PATHWAY PV ATHERECTOMY SYSTEM | Pathway Medical Technologies, Inc. | 2008-08-29 | Special | PDF ↗ |
| K081944 | MODIFICATION TO DIAMONDBACK 360 DEGREE ORBITAL ATHERECTOMY SYSTEM | Cardio Systems, Inc. | 2008-08-14 | Special | PDF ↗ |
| K081328 | PATHWAY PV ATHERECTOMY SYSTEM | Pathway Medical Technologies, Inc. | 2008-07-17 | Traditional | PDF ↗ |
| K071432 | SILVERHAWK-R PERIPHERAL PLAQUE EXCISION SYSTEM FOR SURGICAL USE | Fox Hollow Technologies | 2008-02-12 | Traditional | PDF ↗ |
| K072748 | MODIFICATION TO: DIAMONDBACK 360 ORBITAL ATHERECTOMY SYSTEM | Cardiovascular Systems, Inc. | 2007-11-09 | Special | PDF ↗ |
| K072800 | DIAMONDBACK 360 DEGREE ORBITAL ATHERECTOMY SYSTEM | Cardiovascular Systems, Inc. | 2007-10-25 | Special | PDF ↗ |
| K071427 | DIAMONDBACK 360 DEGREE ORBITAL ATHERECTOMY SYSTEM FOR TREATMENT OF A-V SHUNT STENOSIS | Cardiovascular Systems, Inc. | 2007-08-30 | Special | PDF ↗ |
Product code MCW · Class II · Cardiovascular. Data: openFDA.