FDA.reportPublic FDA data

Laser system

Primary DI
07290017590059
Brand
Laser system
Company
EXIMO MEDICAL LTD
Model
EXM-2001-1100
Device description
100-120 Vac Laser system For Infra Inguinal Atherectomy
Published
2019-03-22
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
MCWCatheter, Peripheral, Atherectomy

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MCWCatheter, Peripheral, AtherectomyCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K181642000
K221077000
K233668000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K181642000B-Laser Atherectomy SystemEximo Medical, Ltd.2018-10-05MCW
K221077000Auryon Atherectomy SystemEximo Medical, Ltd.2022-06-09MCW
K233668000Auryon 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.2023-12-15MCW

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
17290017590056PackageGS11Not in Commercial Distribution
07290017590059PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1729001759005617290017590056
07290017590059072900175900597290017590059

GMDN Terms#

Term, Definition table
TermDefinition
Atherectomy laser system beam guide-catheter, peripheralA sterile, flexible tube intended to be connected to an atherectomy laser system to invasively direct and deliver laser energy into the peripheral vasculature for the intraluminal photoablation or debulking of lesion material (blockages or total occlusions), to re-establish blood flow within the vessel. It typically consists of fibreoptic materials with a laser-firing distal end and may be designed for over-the-wire (OTW) or rapid exchange insertion. This is a single-use device.

Contacts#

Phone, Email table
PhoneEmail
1-480-213-8499roberts@eximomedical.com

Regulatory Flags#

DUNS number
600468941
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07290017590325Auryon Atherectomy CatheterEXM-4012-H000EXM-4012-H0002024-09-16
07290017590332Auryon Atherectomy CatheterEXM-4012-0000EXM-4012-00002024-09-16
07290017590288Auryon Atherectomy CatheterEXM-4010-H000EXM-4010-H0002023-12-28
07290017590295Auryon Atherectomy CatheterEXM-4011-H000EXM-4011-H0002023-12-28
07290017590301Auryon Atherectomy CatheterEXM-4010-0000EXM-4010-00002023-12-28
07290017590318Auryon Atherectomy CatheterEXM-4011-0000EXM-4011-00002023-12-28
07290017590141Auryon Atherectomy CatheterEXM-4001-H000EXM-4001-H0002022-10-04
07290017590158Auryon Atherectomy CatheterEXM-4002-H000EXM-4002-H0002022-10-04
07290017590165Auryon Atherectomy CatheterEXM-4003-H000EXM-4003-H0002022-10-04
07290017590172Auryon Atherectomy CatheterEXM-4004-H000EXM-4004-H0002022-10-04
07290017590066Auryon Atherectomy Catheter 1.5 mm OTWEXM-4001-0000EXM-4001-00002020-05-20
07290017590073Auryon Atherectomy Catheter 0.9 mm OTWEXM-4002-0000EXM-4002-00002020-05-20
07290017590080Auryon Atherectomy Catheter 2.0 mm OTWEXM-4003-0000EXM-4003-00002020-05-20
07290017590097Auryon Atherectomy Catheter 2.35 mm OTWEXM-4004-0000EXM-4004-00002020-05-20
07290017590264AuryonEXM-2002-1000EXM-2002-10002026-06-02
072900175900041.5 mm OTW B-Laser™ catheterEXM-4001-00002019-03-22
072900175900110.9 mm OTW B-Laser™ catheterEXM-4002-00002019-03-22
072900175900282.0 mm OTW B-Laser™ catheterEXM-4003-00002019-03-22
072900175900352.35 mm OTW B-Laser™ catheterEXM-4004-00002019-03-22
07290017590042Laser systemEXM-2001-10002019-03-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07290017590264AuryonEXIMO MEDICAL LTDMCW2026-06-02
06975417183858PantherisZylox-Tonbridge Medical Technology Co., Ltd.MCW2026-03-21
06975417183865PantherisZylox-Tonbridge Medical Technology Co., Ltd.MCW2026-03-21
06975417183872PantherisZylox-Tonbridge Medical Technology Co., Ltd.MCW2026-03-21
06975417183889PantherisZylox-Tonbridge Medical Technology Co., Ltd.MCW2026-03-21
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
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
00763000918910SilverHawk™MEDTRONIC, INC.MCW2024-08-10
00763000918927SilverHawk™MEDTRONIC, INC.MCW2024-08-10
00763000918965Cutter DriverMEDTRONIC, INC.MCW2024-08-10
00845225003463Phoenix 1.5mm x 149cm 4F Atherectomy CatheterPhilips Image Guided Therapy CorporationMCW2024-07-08
00845225003470Phoenix 1.8mm x 130cm 5F Atherectomy CatheterPhilips Image Guided Therapy CorporationMCW2024-07-08
00845225003487Phoenix 1.8mm x 149cm 5F Atherectomy CatheterPhilips Image Guided Therapy CorporationMCW2024-07-08
00845225003494Phoenix 2.2mm x 130cm 6F Atherectomy CatheterPhilips Image Guided Therapy CorporationMCW2024-07-08
00845225003500Phoenix 2.2mm x 149cm 6F Atherectomy CatheterPhilips Image Guided Therapy CorporationMCW2024-07-08
00845225003517Phoenix 2.2mm x 130cm 6F Pre-Deflected Atherectomy CatheterPhilips Image Guided Therapy CorporationMCW2024-07-08