FDA.reportPublic FDA data

Pantheris

Primary DI
06975417183865
Brand
Pantheris
Company
Zylox-Tonbridge Medical Technology Co., Ltd.
Model
A400X
Published
2026-03-21
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
MCWCatheter, Peripheral, Atherectomy
NQQSystem, Imaging, Optical Coherence Tomography (Oct)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MCWCatheter, Peripheral, AtherectomyCardiovascular2
NQQSystem, Imaging, Optical Coherence Tomography (Oct)Radiology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06975417183865PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06975417183865069754171838656975417183865

GMDN Terms#

Term, Definition table
TermDefinition
Mechanical atherectomy system catheter, peripheralA 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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
542983873
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06975417183858PantherisA4002026-03-21
06975417183872PantherisA140-SV2026-03-21
06975417183889PantherisA110-LV2026-03-21

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07290017590264AuryonEXIMO MEDICAL LTDMCW2026-06-02
00199874783659LIA ConsoleLEADOPTIK INC.NQQ2026-06-01
05415067054920Ultreon™LIGHTLAB IMAGING, INC.NQQ2026-05-19
00812763011007OPUSWAVETerumo Cardiovascular Systems CorporationNQQ2026-05-13
06975417183858PantherisZylox-Tonbridge Medical Technology Co., Ltd.MCW2026-03-21
06975417183858PantherisZylox-Tonbridge Medical Technology Co., Ltd.NQQ2026-03-21
06975417183872PantherisZylox-Tonbridge Medical Technology Co., Ltd.MCW2026-03-21
06975417183872PantherisZylox-Tonbridge Medical Technology Co., Ltd.NQQ2026-03-21
06975417183889PantherisZylox-Tonbridge Medical Technology Co., Ltd.MCW2026-03-21
06975417183889PantherisZylox-Tonbridge Medical Technology Co., Ltd.NQQ2026-03-21
00857141005322Revolution Peripheral Atherectomy SystemRex Medical, Inc.MCW2025-12-16
00857141005339Revolution Peripheral Atherectomy SystemRex Medical, Inc.MCW2025-12-16
00857141005346Revolution Peripheral Atherectomy SystemRex Medical, Inc.MCW2025-12-16
00857141005377Revolution Peripheral Atherectomy SystemRex Medical, Inc.MCW2025-12-16
00857141005384Revolution Peripheral Atherectomy SystemRex Medical, Inc.MCW2025-12-16
00857141005391Revolution Peripheral Atherectomy SystemRex Medical, Inc.MCW2025-12-16
00857141005407Revolution Peripheral Atherectomy SystemRex Medical, Inc.MCW2025-12-16
00857141005414Revolution Peripheral Atherectomy SystemRex Medical, Inc.MCW2025-12-16
00810060550793Turbo-Power Laser Atherectomy CatheterPhilips Image Guided Therapy CorporationMCW2025-10-21
00810060550809Turbo-Power Laser Atherectomy CatheterPhilips Image Guided Therapy CorporationMCW2025-10-21
06971141530494Cornaris Intravascular Imaging SystemShenzhen Vivolight Medical Device & Technology Co., Ltd.NQQ2025-09-28
06971141530500Cornaris Intravascular Imaging SystemShenzhen Vivolight Medical Device & Technology Co., Ltd.NQQ2025-09-28
03775000102715deepLiveDAMAE MEDICALNQQ2025-09-24
05415067053879ILUMIEN™ OPTIS™ to OPTIS™LIGHTLAB IMAGING, INC.NQQ2025-07-31
00763000835392HawkOne™MEDTRONIC, INC.MCW2024-12-28
07290017590325Auryon Atherectomy CatheterEXIMO MEDICAL LTDMCW2024-09-16
07290017590332Auryon Atherectomy CatheterEXIMO MEDICAL LTDMCW2024-09-16
00763000918934TurboHawk™MEDTRONIC, INC.MCW2024-08-18
00763000918941TurboHawk™MEDTRONIC, INC.MCW2024-08-18
00763000918958TurboHawk™MEDTRONIC, INC.MCW2024-08-18