FDA.reportPublic FDA data

JETi Thrombectomy System, Sterile Disposable Components Kit, 8Fr

Primary DI
B139WV80031
Brand
JETi Thrombectomy System, Sterile Disposable Components Kit, 8Fr
Company
WALK VASCULAR L.L.C.
Model
WV8003
Published
2018-05-15
Public version status
Update
Distribution status
Not 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
DXECatheter, Embolectomy

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DXECatheter, EmbolectomyCardiovascular2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B139WV80031PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Thrombectomy suction catheterA sterile 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 and stented blood vessels, native and synthetic bypass grafts, and/or haemodialysis access grafts, through suction (aspiration) typically achieved with the use of an included syringe(s) attached to the proximal end of the catheter, or connection to a dedicated suction pump system. Collection baskets may also be included to obtain filtered blood specimens for analyses. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Catheter Gauge8French
Length100Centimeter

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
034774488
Device count
1
Kit
true
Lot or batch
true
Expiration date on label
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
B139WV088F0JETiWV088F2019-06-17
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08886483504455Embolectomy CatheterBIOPTIMAL INTERNATIONAL PTE. LTD.DXE2026-05-04
08886483504486Embolectomy CatheterBIOPTIMAL INTERNATIONAL PTE. LTD.DXE2026-05-04
08886483504516Embolectomy CatheterBIOPTIMAL INTERNATIONAL PTE. LTD.DXE2026-05-04
10841156110512PRONTOTELEFLEX INCORPORATEDDXE2026-03-03
20841156110519PRONTOTELEFLEX INCORPORATEDDXE2026-03-03
00850291007697Large Bore 60 cc SyringeInari Medical, Inc.DXE2024-12-20
00763000762353Amplatz Goose Neck™MEDTRONIC, INC.DXE2024-10-27
00763000762360Amplatz Goose Neck™MEDTRONIC, INC.DXE2024-10-27
00763000762377Amplatz Goose Neck™MEDTRONIC, INC.DXE2024-10-27
00763000762384Amplatz Goose Neck™MEDTRONIC, INC.DXE2024-10-27
00763000762391Amplatz Goose Neck™MEDTRONIC, INC.DXE2024-10-27
00763000762407Amplatz Goose Neck™MEDTRONIC, INC.DXE2024-10-27
00763000762414Amplatz Goose Neck™MEDTRONIC, INC.DXE2024-10-27
00763000762421Amplatz Goose Neck™MEDTRONIC, INC.DXE2024-10-27
00763000762438Amplatz Goose Neck™MEDTRONIC, INC.DXE2024-10-27
08886483507524Embolectomy CatheterBIOPTIMAL INTERNATIONAL PTE. LTD.DXE2023-10-31
00860010378007ICHORICHOR VASCULAR, INC.DXE2023-10-13
10801902196603ARROWTELEFLEX INCORPORATEDDXE2022-11-15
20801902196600ARROWTELEFLEX INCORPORATEDDXE2022-11-15
10801902194043ARROWTELEFLEX INCORPORATEDDXE2022-11-08
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10801902196610ARROWTELEFLEX INCORPORATEDDXE2022-11-08
20801902194040ARROWTELEFLEX INCORPORATEDDXE2022-11-08
20801902194057ARROWTELEFLEX INCORPORATEDDXE2022-11-08
20801902194064ARROWTELEFLEX INCORPORATEDDXE2022-11-08