Atherectomy Devices

102 devices 21 with evidence

Clinical Overview

Devices for plaque debulking in peripheral arterial disease.

Procedures that use atherectomy

Peripheral Atherectomy

Atherectomy Devices by manufacturer

64 product lines from 14 manufacturers registered with the FDA. Sizes are as listed in the FDA device identification database; confirm with the manufacturer's instructions for use.

Manufacturer	Product	Sizes (FDA GUDID)	Models	MRI
Cardiovascular Systems, Inc.	Diamondback Peripheral Diamondback Peripheral, Exchangeable Series, Cartridge, 1.75 Solid, 180 cm shaft, 120krpm High Speed, 90krpm Medium Speed, 60krpm Low Speed Suggest edits	Length: 75–200 cm	37	Not stated
Cardiovascular Systems, Inc.	Stealth STEALTH, CLASSIC, 2.00MM, 145CM SHAFT Suggest edits	Length: 145–200 cm	12	Not stated
Spectranetics Corporation	Turbo-Elite Laser Atherectomy Catheter Suggest edits	Outer Diameter: 0.97–2.6 mm; Length: 112–150 cm	12	Not stated
Eximo Medical Ltd	Auryon Atherectomy Catheter Auryon Atherectomy Catheter 1.7mm - Hydrophilic Coated FDA record Suggest edits	Outer Diameter: 0.9–2.35 mm; Length: 110–225 cm; Lumen/Inner Diameter: 0.01 in	10	Not stated
Covidien LP	SilverHawk Cutter Driver for Plaque Excision Systems Suggest edits	Catheter Gauge: 6–8 Fr; Outer Diameter: 1.9–2.7 mm; Length: 2.2–104 cm	9	Not stated
Rex Medical, Inc.	Revolution Peripheral Atherectomy System Revolution, 6F, 1.66mm, 200cm FDA record Suggest edits	Length: 60–200 cm	8	Not stated
Covidien LP	SilverHawkTM ATHERECTOMY P4055 SILVERHAWK ATK V03 FDA record Suggest edits	—	8	Not stated
Boston Scientific Corporation	Peripheral RotaLink Plus Pre-Connected Exchangeable Burr Catheter and Burr Advancing Device Suggest edits	—	8	Not stated
Boston Scientific Corporation	Peripheral ROTAPRO Rotational Atherectomy Device Suggest edits	Atherectomy Rotating Component Diameter: 1.25–2.5 mm	8	Not stated
Covidien LP	TurboHawk ATHERECTOMY THS-SS-CL TURBOHAWK BTK V03 FDA record Suggest edits	Length: 3.9–145 cm; Outer Diameter: 2.2–2.7 mm; Catheter Gauge: 6–8 Fr	7	Not stated
Volcano Atheromed, Inc.	Phoenix 1.5mm x 149cm 4F Atherectomy Catheter FDA record Suggest edits	Outer Diameter: 1.5–2.4 mm; Length: 130–149 cm	6	Not stated
Volcano Atheromed, Inc.	Phoenix 2.2mm x 130cm 6F Atherectomy System FDA record Suggest edits	Outer Diameter: 1.5–2.4 mm; Length: 130–149 cm	6	Not stated
Covidien LP	HawkOne ATHERECTOMY H1-14550 CUTTER DRIVER UNI FDA record Suggest edits	Catheter Gauge: 6–7 Fr; Outer Diameter: 2.2–2.6 mm; Length: 104–145 cm	5	Not stated
Philips Image Guided Therapy Corporation	Phoenix 2.2mm x 130cm 6F Atherectomy System FDA record Suggest edits	Outer Diameter: 1.5–2.2 mm; Length: 130–149 cm	5	Not stated
Philips Image Guided Therapy Corporation	Phoenix 2.2mm x 149cm 6F Atherectomy Catheter FDA record Suggest edits	Outer Diameter: 1.5–2.2 mm; Length: 130–149 cm	5	Not stated
Medtronic, Inc.	TurboHawk ATHERECTOMY THS-SX-C TURBOHAWK BTK HEC O FDA record Suggest edits	Outer Diameter: 2.7 mm; Length: 104 cm; Catheter Gauge: 7–8 Fr	4	Not stated
Spectranetics Corporation	Turbo Elite Turbo-Elite™ Laser Atherectomy Catheter Suggest edits	Outer Diameter: 2.3–2.6 mm	4	Not stated
Zylox-Tonbridge Medical Technology Co., Ltd.	Pantheris Suggest edits	—	4	Not stated
Medtronic, Inc.	TurboHawk Plus ATHERECTOMY THP-LS TH PLUS 7F STD TIP US FDA record Suggest edits	Catheter Gauge: 6–7 Fr; Length: 104–145 cm; Balloon Diameter: 2.2–2.6 mm	4	Not stated
Spectranetics Corporation	Turbo-Power Turbo-Power™ Laser Atherectomy Catheter FDA record Suggest edits	Outer Diameter: 2–2.3 mm	4	Not stated
Straub Medical AG	SET RotarexS 8 F x 85 cm Rotational Excisional Atherectomy System. The Catheter Set includes one Rotarex™S catheter (gauge 8F; length 110 cm), one guidewire (0.018” diameter; 270cm in… FDA record Suggest edits	Catheter Gauge: 6–8 Fr; Catheter Working Length: 85–135 cm	4	MR Unsafe
Eximo Medical Ltd	Auryon Atherectomy Catheter 1.5 mm OTW Auryon Atherectomy Catheter 2.35 mm OTW FDA record Suggest edits	Outer Diameter: 0.97–2.37 mm; Length: 110–150 cm; Lumen/Inner Diameter: 0.01 in	4	Not stated
Spectranetics Corporation	Turbo Tandem Turbo-Tandem™ Laser Guide Catheter with Laser Atherectomy Catheter FDA record Suggest edits	Length: 110 cm	4	Not stated
Eximo Medical Ltd	1.5 mm OTW B-Laser catheter 1.5 mm OTW B-Laser™ catheter For Infra Inguinal Atherectomy FDA record Suggest edits	—	4	Not stated
Straub Medical AG	RotarexS 8 F x 85 cm The Rotarex™S catheter (gauge 6F; length 135 cm) is over-the-wire, single use, percutaneous device for the treatment of occlusions in arterial vasculature. Suggest edits	Catheter Gauge: 6–8 Fr; Catheter Working Length: 85–135 cm	4	MR Unsafe
Cardiovascular Systems, Inc.	Diamondback DIAMONDBACK PERIPHERAL, MAX CROWN, 2.00MM, 145CM SHAFT Suggest edits	—	3	Not stated
Medtronic, Inc.	SilverHawk ATHERECTOMY P4044 EXL SILVERHAWK BTK UNI FDA record Suggest edits	Outer Diameter: 1.9–2.3 mm; Catheter Gauge: 6–7 Fr; Length: 129–132 cm	3	Not stated
Cardio Flow, Inc.	FreedomFlow Orbital Circumferential Atherectomy System FreedomFlow Orbital Circumferential Atherectomy System Electric User Handle, 6Fr 135 cm, 5-sphere FDA record Suggest edits	Atherectomy Rotating Component Diameter: 1.5–2 mm	3	Not stated
Boston Scientific Corporation	Jetstream PVCN100 Console Suggest edits	—	3	Not stated
Spectranetics Corporation	Turbo-Power Laser Atherectomy Catheter FDA record Suggest edits	Outer Diameter: 2–2.3 mm; Length: 125–150 cm; Lumen/Inner Diameter: 0.02 in	2	Not stated
Bayer Healthcare LLC	Jetstream Xc JETSTREAM XC 2.4MM, FG PKG Suggest edits	Catheter Gauge: 7 Fr	2	Not stated
Volcano Atheromed, Inc.	Phoenix 2.2mm x 130cm 6F Deflecting Atherectomy Catheter FDA record Suggest edits	Outer Diameter: 2.2–2.4 mm; Length: 130 cm	2	Not stated
Bayer Healthcare LLC	Jetstream Sc JETSTREAM SC 1.85MM, FG PKG Suggest edits	Catheter Gauge: 7 Fr	2	Not stated
Boston Scientific Corporation	Jetstream Xc Atherectomy Catheter Suggest edits	—	2	Not stated
Philips Image Guided Therapy Corporation	Turbo-Power Laser Atherectomy Catheter Turbo-Power Laser Atherectomy Catheter, 2.0mm FDA record Suggest edits	Catheter Working Length: 125–150 cm	2	Not stated
Eximo Medical Ltd	Laser system 200-240 Vac Laser system For Infra Inguinal Atherectomy FDA record Suggest edits	—	2	Not stated
Boston Scientific Corporation	Rotaglide Lubricant Suggest edits	—	2	Not stated
Volcano Atheromed, Inc.	Phoenix 2.4mm x 130cm 7F Deflecting Atherectomy System FDA record Suggest edits	Outer Diameter: 2.2–2.4 mm; Length: 130 cm	2	Not stated
Philips Image Guided Therapy Corporation	Phoenix 2.2mm x 130cm 6F Pre-Deflected Atherectomy System FDA record Suggest edits	Outer Diameter: 2.2–2.4 mm; Length: 130 cm	2	Not stated
Boston Scientific Corporation	Rotablator Rotational Atherectomy System Console Kit Rotational Atherectomy System Suggest edits	—	2	Not stated
Boston Scientific Corporation	Jetstream Sc Atherectomy Catheter Suggest edits	—	2	Not stated
Philips Image Guided Therapy Corporation	Phoenix 2.2mm x 130cm 6F Pre-Deflected Atherectomy Catheter FDA record Suggest edits	Outer Diameter: 2.2–2.4 mm; Length: 130 cm	2	Not stated
Avinger, Inc.	Pantheris The Pantheris System is intended to remove plaque (atherectomy) from partially occluded vessels in the peripheral vasculature with a reference diameter of… Suggest edits	—	2	Not stated
Straub Medical AG	RotarexS 8F 85cm (Straub Medical) The Rotarex®S catheter (gauge 8F; length 110 cm) is over-the-wire, single use, percutaneous device for the treatment of occlusions in arterial vasculature. Suggest edits	Catheter Working Length: 85–135 cm; Catheter Gauge: 6–8 Fr	1	MR Unsafe
Covidien LP	TurboHawkTM ATHERECTOMY TH-LS-M TURBOHAWK ATK V06 FDA record Suggest edits	—	1	Not stated
Straub Medical AG	SET RotarexS 8F 85cm (Straub Medical) Rotational Excisional Atherectomy System.The Catheter Set includes one Rotarex®S catheter (gauge 8F; length 85 cm), one guidewire (0.018” diameter; 220cm in length),… FDA record Suggest edits	Catheter Working Length: 85–135 cm; Catheter Gauge: 6–8 Fr	1	MR Unsafe
Straub Medical AG	Footswitch (Straub Medical) The footswitch is a pedal that allows the physician to turn the Motor on and off by pressing down the switch, if… Suggest edits	—	1	MR Unsafe
Straub Medical AG	Motor (with cord) (Straub Medical) The Handle / Motor transmits the power between the Control Unit and the catheter. The Handle contains an electric Motor and a… Suggest edits	—	1	MR Unsafe
Medtronic, Inc.	Na ATHERECTOMY FG02550 CUTTERDRIVER FDA record Suggest edits	—	1	Not stated
Avinger, Inc.	Pantheris SV The Pantheris SV System is intended to remove plaque (atherectomy) from partially occluded vessels in the peripheral vasculature with a reference diameter… Suggest edits	—	1	Not stated
Medtronic, Inc.	Cutter Driver ATHERECTOMY FG02550 CUTTERDRIVER UNI FDA record Suggest edits	—	1	Not stated
Straub Medical AG	Power Cord US (Straub Medical) Power cord powers whole Drives System. The power cord is a part of Straub Medical Drive System. Suggest edits	—	1	MR Unsafe
Boston Scientific Corporation	Rotablator Dynaglide™ Foot Pedal Suggest edits	—	1	Not stated
Eximo Medical Ltd	Auryon Laser System 100-120 Vac FDA record Suggest edits	—	1	Not stated
Covidien LP	HawkOneTM ATHERECTOMY H1-14550 CUTTERDRIVER V02 FDA record Suggest edits	—	1	Not stated
Avinger, Inc.	Pantheris LV The Pantheris LV Catheter is a monorail (rapid exchange) device with an effective length of 110 cm, compatible with standard 7F sheaths… FDA record Suggest edits	Length: 6–110 cm	1	Not stated
Bayer Healthcare LLC	Jetstream JETSTREAM CONSOLE Suggest edits	Catheter Gauge: 7 Fr	1	Not stated
Volcano Atheromed, Inc.	Phoenix 2.4mm 7F Deflecting Atherectomy Catheter Suggest edits	Outer Diameter: 2.4 mm; Length: 127 cm	1	Not stated
Medtronic, Inc.	HawkOne ATHERECTOMY H1-14550 CUTTER DRIVER UNI FDA record Suggest edits	—	1	Not stated
Eximo Medical Ltd	Auryon Auryon Laser System 200-240V FDA record Suggest edits	—	1	Not stated
Straub Medical AG	Control Unit (with cord) (Straub Medical) The control unit console contains the power supply, system controller, mode selectors, and has auditory and visual alarms to signify irregularities in… Suggest edits	—	1	MR Unsafe
Volcano Atheromed, Inc.	Phoenix 2.4mm 7F Deflecting Atherectomy System Suggest edits	Outer Diameter: 2.4 mm; Length: 127 cm	1	Not stated
Covidien LP	N/A ATHERECTOMY FG02550 CUTTERDRIVER V04 FDA record Suggest edits	—	1	Not stated
Straub Medical AG	Drive System (Straub Medical) The Drive System consists of three components; the control unit, motor (with cable) and footswitch (with cable). Suggest edits	—	1	MR Unsafe

All Manufacturers Adac Laboratories Atheromed Avinger Bard Peripheral Vascular Boston Scientific C.R. Bard Cardio Flow Inc., Cardio Systems Cardiovascualr Systems Cardiovascular System Cardiovascular Systems Covidien Deldent Dove Systems Eminent Spine Ev3 Eximo Medical Fox Hollow Technologies Foxhollow Technologies Intensive Technology Medrad Medtronic Medtronic Vascular Northeast Scientific Pathway Medical Technologies Possis Medical Rex Medical, L.P. Spectranetics Volcano Atheromed All Pathways 510K PMA Any Evidence Level 1+ Studies 2+ Studies 5+ Studies 10+ Studies Filter Clear Filters

Device	Manufacturer	Pathway	Cleared	Evidence
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	510(k)	2023	419
Auryon Atherectomy Catheter 1 7mm Auryon Atherectomy Catheter 1 7mm Hydrophilic Coating	Eximo Medical	510(k)	2024	419
Modification to Diamondback 360 Degree Orbital Atherectomy System Evidence	Cardio Systems	510(k)	2008	19
Diamondback 360 Orbital Atherectomy System Stealth 360 Orbital Pad System Evidence	Cardiovascular Systems	510(k)	2011	19
Diamondback 360 Peripheral Orbital Atherectomy System Evidence Other clearances: 2015, 2015, 2014, 2013	Cardiovascular Systems	510(k)	2017	19
Viperwire Advance Guide Wire Stealth 360 Orbital Peripheral Atherectomy Device Pad Diamondback 360 Peripheral Atherectomy System	Cardiovascular Systems	510(k)	2018	19
Diamondback 360 Peripheral Orbital Atherectomy System Exchangeable Series Evidence	Cardiovascular Systems	510(k)	2018	19
Diamondback 360 Peripheral Orbital Atherectomy System Stealth 360 Peripheral Orbital Atherectomy System Evidence	Cardiovascular Systems	510(k)	2019	19
Diamondback 360 Degree Orbital Atherectomy System with Viperslide Lubricant Evidence	Cardiovascular Systems	510(k)	2008	19
Diamondback 360 Degree Orbital Atherectomy System Evidence Other clearances: 2007	Cardiovascular Systems	510(k)	2007	19
Diamondback 360 Peripheral Orbital Atherectomy System Diamondback 360 Peripheral Orbital Atherectomy System Exchangeable Series Stealth 360 Peripheral Orbital Atherectomy System Evidence Other clearances: 2020	Cardiovascular Systems	510(k)	2022	19
Diamondback 360 Peripheral Orbital Atherectomy System Stealth 360 Peripheral Orbital Atherectomy System Diamondback 360 Peripheral Orbital Atherectomy System Exchangeable Series Evidence	Cardiovascualr Systems	510(k)	2022	19
Diamondback Spinal System	Eminent Spine	510(k)	2010	19
Diamondback 360 Dbx	Cardiovascular Systems	510(k)	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	510(k)	2007	19
Diamonback 360 Peripheral Orbital Atherectomy System Diamondback 360 Stealth Orbital Atherectomy System Evidence	Cardiovascular Systems	510(k)	2021	19
Viperwire Advance Guide Wire Diamondback 360 Peripheral Orbital Atherectomy System Stealth 360 Orbital Pad	Cardiovascular System	510(k)	2015	19
Modification to Diamondback 360 Orbital Atherectomy System Evidence	Cardiovascular Systems	510(k)	2007	19
Jetstream Navitus L System Jeystream Navitus System Jetstream G3 Sf System Jetstream Sf 1 6 System	Medrad	510(k)	2012	18
Jetstream G3 System Model PV31300 Pv Console Model PVCN100	Pathway Medical Technologies	510(k)	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	510(k)	2013	18
Jetstream Pathway Pv Atherectomy System Model PV10300 PVCN100	Pathway Medical Technologies	510(k)	2008	18
Jetstream Evidence	Deldent	510(k)	2002	18
Jetstream G3 L System Model PV31400 Jetstream G3 L Catheter with Control Pod PVCN100 Pv Console	Pathway Medical Technologies	510(k)	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	510(k)	2010	18
Jetstream G3 L System Pv Console Models PV31400 PV31300 PVCN100	Pathway Medical Technologies	510(k)	2010	18
Jetstream G2 System Models PV20300 Jetstream G2 Catheter and Control Pod PVCN100 Pv Console Other clearances: 2009	Pathway Medical Technologies	510(k)	2009	18
Jetstream Cavity Preparation System	Dove Systems	510(k)	1996	18
Jetstream G3 System Model PV31300 Jetstream G3 Catheter and Control Pod PVCN100 Pv Console	Pathway Medical Technologies	510(k)	2009	18
Jetstream Pathway Pc Atherectomy System Model OV10300	Pathway Medical Technologies	510(k)	2009	18
Ensphere Tempo Jetstream Workspace Cardiology Module	Adac Laboratories	510(k)	2004	18
Jetstream Navitus System Jetstream G3 Sf System Jetstream G3 Se System Jetstream G3 L System	Pathway Medical Technologies	510(k)	2011	18
Jetstream G2 Nxt System Model PV20300	Pathway Medical Technologies	510(k)	2009	18
Jetstream Xc 2 4 3 4 Jetstream Xc 2 1 3 0 Jetstream Sc 1 85 Jetstream Sc 1 6	Medrad	510(k)	2014	18
Jetstream G3 R Sf 1 6 System	Pathway Medical Technologies	510(k)	2011	18
Jetstream Workspace Other clearances: 2004	Adac Laboratories	510(k)	2006	18
Jetstream Navitus L System	Pathway Medical Technologies	510(k)	2012	18
Jetstream G3 System	Pathway Medical Technologies	510(k)	2009	18
1 8mm x 149cm Phoenix Atherectomy System 2 2mm x 149cm Phoenix Atherectomy System 2 4mm x 130cm Phoenix Atherectomy System	Volcano Atheromed	510(k)	2017	8
Phoenix 5f Tracking Atherectomy Catheter Phoenix 6f Tracking Atherectomy Catheter Phoenix 7d Deflecting Atherectomy Ca	Atheromed	510(k)	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	510(k)	2014	8