ClearanceBrief
Panels › Cardiovascular › Product code MCW · Class 2

Catheter, Peripheral, Atherectomy

Regulation 870.4875

1510(k)s in 12 months (146 all time)
0recalls in 12 months (34 all time)
33recalls that name a 510(k)
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Top companies in MCW

Company510(k)sRecalls
Cardiovascular Systems Incorporated2112
Pathway Medical Technologies, Inc.160
Spectranetics105
Ev3 Corporation47
Avinger, Inc.100
Eximo Medical80
Rex Medical80
Boston Scientific Corp51
Volcano Atheromed, Inc.60
Cardio Flow Inc.,40
Decided510(k)Device and applicantCode
Apr 10, 2026K260244Auryon Atherectomy System
Eximo Medical, IL
MCW
Apr 25, 2025K250723FreedomFlow™ Orbital Circumferential Atherectomy System (H6005/ 4Fr 3-Sphere Configuration)
Cardio Flow Inc.,
MCW
Mar 13, 2025K250385Turbo-Elite Laser Atherectomy Catheter
Spectranetics
MCW
Jan 30, 2025K242757Rotarex Atherectomy System
Bard Peripheral Vascular, Inc.
MCW
Nov 5, 2024K242947FreedomFlow™ Orbital Circumferential Atherectomy System
Cardio Flow Inc.,
MCW
Jun 27, 2024K241553Auryon Atherectomy Catheter 1.7mm; Auryon Atherectomy Catheter 1.7mm, Hydrophilic Coating
Eximo Medical, Ltd., IL
MCW
Feb 15, 2024K233483FreedomFlow Orbital Circumferential Atherectomy System (H6004/5Fr 3-Sphere Configuration)
Cardio Flow Inc.,
MCW
Dec 15, 2023K233668Auryon Atherectomy Catheter 1.5 mm XL, Hydrophilic Coating (EXM-4010-H000), Auryon Atherectomy Catheter 0.9 mm XL, Hydro
Eximo Medical, Ltd., IL
MCW
Sep 27, 2023K231538FreedomFlow Orbital Circumferential Atherectomy System
Cardio Flow Inc.,
MCW
Jun 9, 2023K230709Auryon Atherectomy System
Eximo Medical, Ltd., IL
MCW
Jun 6, 2023K230005Pantheris LV Atherectomy Catheter
Avinger, Inc.
MCW
Dec 8, 2022K222837Turbo-Power (2.0mm) Laser Atherectomy Catheters, Turbo-Power (2.3mm) Laser Atherectomy Catheters
Spectranetics, Inc.
MCW
Sep 26, 2022K220116Auryon Atherectomy Catheters
Eximo Medical, Ltd., IL
MCW
Sep 6, 2022K220962ROTAPRO Rotational Atherectomy System
Boston Scientific Corporation
MCW
Jun 9, 2022K221077Auryon Atherectomy System
Eximo Medical, Ltd., IL
MCW
Apr 27, 2022K220568Diamondback 360 Peripheral Orbital Atherectomy System, Stealth 360 Peripheral Orbital Atherectomy System, Diamondback 36
Cardiovascualr Systems, Inc.
MCW
Mar 1, 2022K220109DIAMONDBACK 360 Peripheral Orbital Atherectomy System, DIAMONDBACK 360 Peripheral Orbital Atherectomy System, Exchangeab
Cardiovascular Systems, Inc.
MCW
Dec 15, 2021K212351Revolution Peripheral Atherectomy System
Rex Medical, L.P.
MCW
Nov 16, 2021K212047Pantheris System
Avinger, Inc.
MCW
Sep 14, 2021K211738Rotarex Atherectomy System
C.R. Bard, Inc.
MCW
Sep 14, 2021K210586Diamonback 360 Peripheral Orbital Atherectomy System, Diamondback 360 Stealth Orbital Atherectomy system
Cardiovascular Systems, Inc.
MCW
Aug 24, 2021K212027TurboHawk Plus Directional Atherectomy System
Medtronic, Inc.
MCW
Jun 14, 2021K2115182.4mm X 130cm Phoenix Deflecting Atherectomy System, 1.5mm X 149cm Phoenix Atherectomy System
Volcano Atheromed, Inc.
MCW
Dec 2, 2020K202835Auryon Atherectomy System
Eximo Medical, Ltd., IL
MCW
Nov 19, 2020K203008DIAMONDBACK 360 Peripheral Orbital Atherectomy System, DIAMONDBACK 360 Peripheral Orbital Atherectomy System, Exchangeab
Cardiovascular Systems, Inc.
MCW
Sep 12, 2019K191419Revolution Peripheral Atherectomy System, Revolution Peripheral Atherectomy Guidewire
Rex Medical, L.P.
MCW
Jul 2, 2019K190634Diamondback 360 Peripheral Orbital Atherectomy System, Stealth 360 Peripheral Orbital Atherectomy System
Cardiovascular Systems, Inc.
MCW
Apr 9, 2019K182341Pantheris SV
Avinger, Inc.
MCW
Dec 20, 2018K182972Phoenix Atherectomy System
Volcano Atheromed, Inc.
MCW
Dec 17, 2018K181877Phoenix 2.4mm Atherectomy Plus System
Volcano Atheromed, Inc.
MCW
Dec 13, 2018K182397Diamondback 360 Peripheral Orbital Atherectomy System Exchangeable Series
Cardiovascular Systems, Inc.
MCW
Oct 5, 2018K181642B-Laser Atherectomy System
Eximo Medical, Ltd., IL
MCW
May 22, 2018K173862Pantheris System
Avinger, Inc.
MCW
Apr 17, 2018K180416ViperWire Advance Guide Wire, Stealth 360 Orbital Peripheral Atherectomy Device (PAD), DIAMONDBACK 360 Peripheral Athere
Cardiovascular Systems, Inc.
MCW
Apr 12, 2018K172315Straub Endovascular System
Straub Medical AG, CH
MCW
Apr 5, 2018K180694Turbo-Power (2.0mm) Laser Atherectomy Catheters, Turbo-Power (2.3mm) Laser Atherectomy Catheters
Spectranetics, Inc.
MCW
Nov 27, 2017K172687Turbo-Power (2.0mm) Laser Atherectomy Catheters, Turbo-Power (2.3mm) Laser Atherectomy Catheters
Spectranetics, Inc.
MCW
Oct 30, 2017K172236Pantheris Catheter (8F), Pantheris Catheter (7F), Lightbox HS Imaging Console, Lightbox Sled
Avinger, Inc.
MCW
Aug 24, 2017K1723861.8mm X 149cm Phoenix Atherectomy System, 2.2mm X 149cm Phoenix Atherectomy System, 2.4mm X 130cm Phoenix Atherectomy Sy
Volcano Atheromed, Inc.
MCW
Jun 16, 2017K170191SilverHawk Peripheral Plaque Excision System, TurboHawk Peripheral Plaque Excision System
Medtronic Vascular, Inc.
MCW
Jun 9, 2017K170792Diamondback 360 Peripheral Orbital Atherectomy System
Cardiovascular Systems, Inc.
MCW
Apr 7, 2017K170059Spectranetics Turbo-Elite Laser Atherectomy Catheters
Spectranetics, Inc.
MCW
Jan 5, 2017K162561Turbo-Power (2.0mm) Laser Atherectomy Catheters
Spectranetics, Inc.
MCW
Dec 21, 2016K163264Pantheris Catheter (8F); Pantheris Cather (7F); Lightbox HS Imaging Console; Lightbox Sled
Avinger, Inc.
MCW
Oct 18, 2016K162326Pantheris Catheter, Lightbix HS Imaging Console, Lightbox Sled
Avinger, Inc.
MCW
Oct 14, 2016K161361HawkOne Directional Atherectomy System
Medtronic Vascular, Inc.
MCW
Apr 21, 2016K160827Pantheris Catheter
Avinger, Inc.
MCW
Mar 1, 2016K153460Pantheris Catheter (8Fr), Pantheris Catheter (7Fr)
Avinger, Inc.
MCW
Nov 12, 2015K152181Turbo-Power Laser Atherectomy Catheter
Spectranetics, Inc.
MCW
Oct 21, 2015K152694Diamondback 360 Peripheral Orbital Atherectomy System
Cardiovascular Systems, Inc.
MCW

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