FDA.reportPublic FDA data

Mechanical atherectomy system catheter, peripheral

Definition
A sterile, flexible tube (catheter) intended to be percutaneously introduced for the intraluminal mechanical disruption of atheroma plaque from the walls of peripheral arteries. It has a power-driven cutting or abrasive head for slicing/grinding the atheroma into fragments small enough to be aspirated or absorbed. This device is not intended for use in the coronary, carotid, iliac or renal vasculature. This is a single-use device.
GUDID devices
195
Last updated
2026-07-30 21:31:02

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
06975417183858PantherisZylox-Tonbridge Medical Technology Co., Ltd.A4002026-03-21
06975417183865PantherisZylox-Tonbridge Medical Technology Co., Ltd.A400X2026-03-21
06975417183872PantherisZylox-Tonbridge Medical Technology Co., Ltd.A140-SV2026-03-21
08714729889830JETSTREAM™ SCBOSTON SCIENTIFIC CORPORATION112260-0012016-09-24
08714729889861JETSTREAM™ SCBOSTON SCIENTIFIC CORPORATION112262-0012016-09-24
08714729889892JETSTREAM™ XCBOSTON SCIENTIFIC CORPORATION112264-0012016-09-24
08714729889922JETSTREAM™ XCBOSTON SCIENTIFIC CORPORATION112266-0012016-09-24
00857141005322Revolution Peripheral Atherectomy SystemRex Medical, Inc.20061451332025-12-16
00857141005339Revolution Peripheral Atherectomy SystemRex Medical, Inc.2006145166LP2025-12-16
00857141005346Revolution Peripheral Atherectomy SystemRex Medical, Inc.2006145200LP2025-12-16
00857141005377Revolution Peripheral Atherectomy SystemRex Medical, Inc.20061452332025-12-16
00857141005384Revolution Peripheral Atherectomy SystemRex Medical, Inc.20062001332025-12-16
00857141005391Revolution Peripheral Atherectomy SystemRex Medical, Inc.20062001662025-12-16
00857141005407Revolution Peripheral Atherectomy SystemRex Medical, Inc.20062002002025-12-16
00857141005414Revolution Peripheral Atherectomy SystemRex Medical, Inc.20060601332025-12-16
10850000491011Diamondback PeripheralCardiovascular Systems, Inc.DBP-CART-150CLA1452019-06-18
10850000491028Diamondback PeripheralCardiovascular Systems, Inc.DBP-CART-200CLA1452019-06-18
10850000491035Diamondback PeripheralCardiovascular Systems, Inc.DBP-EX-HANDLE2019-06-18
10852528005008Diamondback PeripheralCardiovascular Systems, Inc.DBP-CART-175SOL1802019-06-18
10852528005015StealthCardiovascular Systems, Inc.DBE-1502015-12-04
10852528005022StealthCardiovascular Systems, Inc.DBE-2002015-12-04
10852528005039StealthCardiovascular Systems, Inc.PRD-SC30-1252015-12-04
10852528005046StealthCardiovascular Systems, Inc.PRD-SC30-1502015-12-04
10852528005053StealthCardiovascular Systems, Inc.PRD-SC30-2002015-12-04
10852528005060StealthCardiovascular Systems, Inc.PRD-SC30-125S2015-12-04
10852528005190Diamondback Peripheral Cardiovascular Systems, Inc.DBP-125MICRO1452015-12-04
10852528005275Diamondback PeripheralCardiovascular Systems, Inc.DBP–200SOLID1452015-12-04
10852528005343StealthCardiovascular Systems, Inc.PRD-SC30-2252016-01-11
10852528005756StealthCardiovascular Systems, Inc.RAD-SC30-1252018-06-21
10852528005763StealthCardiovascular Systems, Inc.RAD-SC30-1502018-06-21
10852528005770StealthCardiovascular Systems, Inc.RAD-SC30-1752018-06-21
10852528005817Diamondback PeripheralCardiovascular Systems, Inc.DBP-EX-125MIC1452019-02-04
10852528005824Diamondback PeripheralCardiovascular Systems, Inc.DBP-EX-125SOL1452019-02-04
10852528005831Diamondback PeripheralCardiovascular Systems, Inc.DBP-EX-150SOL1452019-02-04
10852528005848Diamondback PeripheralCardiovascular Systems, Inc.DBP-EX-200SOL1452019-02-04
10852528005862Diamondback PeripheralCardiovascular Systems, Inc.DBP-EX-125SOL752019-02-04
10852528005879Diamondback PeripheralCardiovascular Systems, Inc.DBP-EX-125SOL2002019-02-04
10852528005886Diamondback PeripheralCardiovascular Systems, Inc.DBP-EX-150SOL2002019-02-04
10852528005893Diamondback PeripheralCardiovascular Systems, Inc.DBP-EX-175SOL1802019-02-04
10852528005909Diamondback PeripheralCardiovascular Systems, Inc.DBP-EX-150CLA1452019-02-04
10852528005916Diamondback PeripheralCardiovascular Systems, Inc.DBP-EX-200CLA1452019-02-04
10852528005923Diamondback PeripheralCardiovascular Systems, Inc.DBP-CART-125MIC1452019-02-04
10852528005930Diamondback PeripheralCardiovascular Systems, Inc.DBP-CART-125SOL1452019-02-04
10852528005947Diamondback PeripheralCardiovascular Systems, Inc.DBP-CART-150SOL1452019-02-04
10852528005954Diamondback PeripheralCardiovascular Systems, Inc.DBP-CART-200SOL1452019-02-04
10852528005961Diamondback PeripheralCardiovascular Systems, Inc.DBP-CART-125MIC752019-02-04
10852528005978Diamondback PeripheralCardiovascular Systems, Inc.DBP-CART-125SOL752019-06-18
10852528005985Diamondback PeripheralCardiovascular Systems, Inc.DBP-CART-125SOL2002019-06-18
10852528005992Diamondback PeripheralCardiovascular Systems, Inc.DBP-CART-150SOL2002019-06-18
10852528005206Diamondback PeripheralCardiovascular Systems, Inc.DBP-125MICRO602015-12-04
10852528005213Diamondback PeripheralCardiovascular Systems, Inc.DBP-125SOLID602015-12-04
10852528005237Diamondback PeripheralCardiovascular Systems, Inc.DBP-150SOLID1452015-12-04
10852528005244Diamondback PeripheralCardiovascular Systems, Inc.DBP-125SOLID1452015-12-04
10852528005251Diamondback PeripheralCardiovascular Systems, Inc.DBP–150CLASS1452015-12-04
10852528005268Diamondback PeripheralCardiovascular Systems, Inc.DBP–200CLASS1452015-12-04
10852528005282Diamondback PeripheralCardiovascular Systems, Inc.DBP-125MICRO1452015-12-04
10852528005350Diamondback PeripheralCardiovascular Systems, Inc.DBP-125SOLID2002017-09-01
10852528005367Diamondback PeripheralCardiovascular Systems, Inc.DBP-150SOLID2002017-09-01
10852528005374Diamondback PeripheralCardiovascular Systems, Inc.DBP-175SOLID1802017-09-01
10852528005855Diamondback PeripheralCardiovascular Systems, Inc.DBP-EX-125MIC752019-02-04
00763000835392HawkOne™MEDTRONIC, INC.H1-145502024-12-28
00763000918934TurboHawk™MEDTRONIC, INC.TH-LX-M2024-08-18
00763000918941TurboHawk™MEDTRONIC, INC.THS-SS-CL2024-08-18
00763000918958TurboHawk™MEDTRONIC, INC.THS-SX-C2024-08-18
00763000918910SilverHawk™MEDTRONIC, INC.P40282024-08-10
00763000918927SilverHawk™MEDTRONIC, INC.P40442024-08-10
00763000918965Cutter DriverMEDTRONIC, INC.FG025502024-08-10
00845225003463Phoenix 1.5mm x 149cm 4F Atherectomy CatheterPhilips Image Guided Therapy CorporationP151492024-07-08
00845225003470Phoenix 1.8mm x 130cm 5F Atherectomy CatheterPhilips Image Guided Therapy CorporationP181302024-07-08
00845225003487Phoenix 1.8mm x 149cm 5F Atherectomy CatheterPhilips Image Guided Therapy CorporationP181492024-07-08
00845225003494Phoenix 2.2mm x 130cm 6F Atherectomy CatheterPhilips Image Guided Therapy CorporationP221302024-07-08
00845225003500Phoenix 2.2mm x 149cm 6F Atherectomy CatheterPhilips Image Guided Therapy CorporationP221492024-07-08
00845225003517Phoenix 2.2mm x 130cm 6F Pre-Deflected Atherectomy CatheterPhilips Image Guided Therapy CorporationPD221302024-07-08
00845225003524Phoenix 2.4mm x 130cm 7F Pre-Deflected Atherectomy CatheterPhilips Image Guided Therapy CorporationPD241302024-07-08
00845225003531Phoenix 1.5mm x 149cm 4F Atherectomy SystemPhilips Image Guided Therapy CorporationP15149K2024-07-08
00845225003548Phoenix 1.8mm x 130cm 5F Atherectomy SystemPhilips Image Guided Therapy CorporationP18130K2024-07-08
00845225003555Phoenix 1.8mm x 149cm 5F Atherectomy SystemPhilips Image Guided Therapy CorporationP18149K2024-07-08
00845225003562Phoenix 2.2mm x 130cm 6F Atherectomy SystemPhilips Image Guided Therapy CorporationP22130K2024-07-08
00845225003579Phoenix 2.2mm x 149cm 6F Atherectomy SystemPhilips Image Guided Therapy CorporationP22149K2024-07-08
00845225003586Phoenix 2.2mm x 130cm 6F Pre-Deflected Atherectomy SystemPhilips Image Guided Therapy CorporationPD22130K2024-07-08