FDA.reportPublic FDA data

JETi

Primary DI
B139WV088F0
Brand
JETi
Company
WALK VASCULAR L.L.C.
Model
WV088F
Device description
Peripheral Catheter - 8 Fr
Published
2019-06-17
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
QEZAspiration Thrombectomy Catheter

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
QEZAspiration Thrombectomy CatheterCardiovascular2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B139WV088F1PackageHIBCC1In Commercial Distribution
B139WV088F0PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Thrombectomy suction catheterA flexible or semi-flexible tube designed for the percutaneous, transluminal disruption and removal of clotted blood (i.e., a thrombus or thromboembolus) or other formed elements causing vascular obstruction in native/stented blood vessels, native/synthetic bypass grafts, and/or haemodialysis access grafts, through suction (aspiration) in conjunction with a syringe or dedicated suction pump system (pump not included). It may additionally be intended for infusion of fluids and/or used as a guide-catheter to facilitate introduction of a thrombectomy wire-net (not included) to remove residual thrombus. Collection containers may be included with the catheter. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Catheter Gauge8French
Catheter Working Length100Centimeter

Sterilization Methods#

Method table
Method
Ethylene Oxide

Regulatory Flags#

DUNS number
034774488
Device count
1
Lot or batch
true
Expiration date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B139WV00161JETi Accessory Cart Attachment KitWV00162019-06-17
B139WV001611JETi Accessory Cart Attachment KitWV0016-12019-06-17
B139WV1500A1JETi All In One Non-Sterile KitWV1500A2021-09-10
B139WVTUB11JETi All In One Accessory KitWVTUB12021-02-26
B139WV008F0JETi Peripheral CatheterWV008F2018-01-24
B139WV008F10JETi Peripheral Catheter WV008F-12018-05-15
B139WV0613507040ClearLumen II Peripheral CatheterWV0613507-042018-01-24
B139WV062F0JETiWV062F2019-06-17
B139WV062F10JETi Peripheral CatheterWV062F-12019-06-17
B139WV088F10JETi Peripheral CatheterWV088F-12019-06-17
B139WV61200JETi Peripheral CatheterWV61202019-02-08
B139WV6120OUS0JETi Peripheral CatheterWV6120-OUS2018-06-21
B139WV6120US0JETi Peripheral CatheterWV6120-US2018-01-24
B139WV0006010JETi Peripheral CatheterWV0006-01WV0006-012017-07-17
B139WV0006011JETi Peripheral CatheterWV0006-01WV0006-012017-07-17
B139WV81000JETi Peripheral CatheterWV8100WV81002017-08-21
B139WV03450JETi Saline Drive UnitWV03452019-06-17
B139WV034510JETi Saline Drive UnitWV0345-12019-06-17
B139WV60031JETi Thrombectomy System, Sterile Disposable Components KitWV60032019-02-08
B139WV600311JETi Thrombectomy System, Sterile Disposable Components KitWV6003-12019-02-08

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00860011713135FLOWRUNNER 7F Aspiration System, 130cmExpanse Medical, Inc.QEZ2026-05-28
00860011713159FLOWRUNNER SP 7F Aspiration System, 130cmExpanse Medical, Inc.QEZ2026-05-28
00763000998011Liberant™MEDTRONIC, INC.QEZ2026-05-09
10841156110505PRONTOTELEFLEX INCORPORATEDQEZ2026-03-30
00851279008910pVasc Aspiration Catheter 70, 115 cmVesalioQEZ2026-03-26
00851279008927pVasc Aspiration Catheter 70, 125 cmVesalioQEZ2026-03-26
00851279008934pVasc Aspiration Catheter 70, 132 cmVesalioQEZ2026-03-26
00851279008941pVasc Aspiration Catheter 70, 140 cmVesalioQEZ2026-03-26
00860011713104FLOWRUNNER 14F Aspiration System, 80cmExpanse Medical, Inc.QEZ2026-01-12
00860011713111FLOWRUNNER 12F Aspiration System, 120cmExpanse Medical, Inc.QEZ2026-01-12
00860011713128FLOWRUNNER 12F Aspiration System, 80cmExpanse Medical, Inc.QEZ2026-01-12
00860011713142FLOWRUNNER 14F Aspiration System, 120cmExpanse Medical, Inc.QEZ2026-01-12
00860011713166FLOWRUNNER 12F Aspiration System, 100cmExpanse Medical, Inc.QEZ2026-01-12
00860011713180FLOWRUNNER 14F Aspiration System, 100cmExpanse Medical, Inc.QEZ2026-01-12
B090P110900VentiV ScientificZIEN MEDICAL TECHNOLOGIES, INC.QEZ2025-11-24
B090P11090F0VentiV ScientificZIEN MEDICAL TECHNOLOGIES, INC.QEZ2025-11-24
B090P110901VentiV ScientificZIEN MEDICAL TECHNOLOGIES, INC.QEZ2025-11-24
B090P11090F1VentiV ScientificZIEN MEDICAL TECHNOLOGIES, INC.QEZ2025-11-24
10841156110482PRONTOTELEFLEX INCORPORATEDQEZ2025-09-17
20841156110489PRONTOTELEFLEX INCORPORATEDQEZ2025-09-17
10841156110475PRONTOTELEFLEX INCORPORATEDQEZ2025-08-25
20841156110472PRONTOTELEFLEX INCORPORATEDQEZ2025-08-25
10841156110499PRONTOTELEFLEX INCORPORATEDQEZ2025-03-18
20841156110496PRONTOTELEFLEX INCORPORATEDQEZ2025-03-18
15051684025966AlphaVacAngiodynamics, Inc.QEZ2024-09-27
15051684025959AlphaVacAngiodynamics, Inc.QEZ2024-09-27
15051684025942AlphaVacAngiodynamics, Inc.QEZ2024-09-27
00813132029869QuickClear Aspiration PumpPhilips Image Guided Therapy CorporationQEZ2023-06-09
B090ASP10130Control 7F Mechanical Thrombectomy SystemZIEN MEDICAL TECHNOLOGIES, INC.QEZ2023-05-03
B090ASP10210Control 11F Mechanical Thrombectomy SystemZIEN MEDICAL TECHNOLOGIES, INC.QEZ2023-05-03