FDA.reportPublic FDA data

Auryon Atherectomy Catheter 2.35 mm OTW

Primary DI
07290017590097
Brand
Auryon Atherectomy Catheter 2.35 mm OTW
Company
EXIMO MEDICAL LTD
Model
EXM-4004-0000
Catalog number
EXM-4004-0000
Device description
Auryon Atherectomy Catheter 2.35 mm OTW
Published
2020-05-20
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
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
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
07290017590097PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07290017590097072900175900977290017590097

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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length0
Lumen/Inner Diameter0
Outer Diameter0

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature00

Contacts#

Phone, Email table
PhoneEmail
+1(800)772-6446customerservice@angiodynamics.com

Regulatory Flags#

DUNS number
600468941
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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
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
07290017590059Laser systemEXM-2001-11002019-03-22

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