FDA.reportPublic FDA data

2.35 mm OTW B-Laser™ catheter

Primary DI
07290017590035
Brand
2.35 mm OTW B-Laser™ catheter
Company
EXIMO MEDICAL LTD
Model
EXM-4004-0000
Device description
2.35 mm OTW B-Laser™ catheter 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
Sterile
true
Single use
true

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

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K181642000B-Laser Atherectomy SystemEximo Medical, Ltd.2018-10-05MCW

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
17290017590032PackageGS111Not in Commercial Distribution
07290017590035PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1729001759003217290017590032
07290017590035072900175900357290017590035

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
Lot or batch
true
Serial number
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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
07290017590042Laser systemEXM-2001-10002019-03-22
07290017590059Laser systemEXM-2001-11002019-03-22
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
07290017590110Auryon Laser System 100-120 VacEXM-2001-1100EXM-2001-11002020-05-20
07290017590141Auryon Atherectomy CatheterEXM-4001-H0002022-10-04
07290017590158Auryon Atherectomy CatheterEXM-4002-H0002022-10-04
07290017590165Auryon Atherectomy CatheterEXM-4003-H0002022-10-04
07290017590172Auryon Atherectomy CatheterEXM-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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
00845225003524Phoenix 2.4mm x 130cm 7F Pre-Deflected Atherectomy CatheterPhilips Image Guided Therapy CorporationMCW2024-07-08