FDA.reportPublic FDA data

JETi Peripheral Catheter

Primary DI
B139WV008F10
Brand
JETi Peripheral Catheter
Company
WALK VASCULAR L.L.C.
Model
WV008F-1
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
B139WV008F11PackageHIBCC1Not in Commercial Distribution
B139WV008F10PrimaryHIBCC0

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
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
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
B139WV600311JETi Thrombectomy System, Sterile Disposable Components KitWV6003-12019-02-08

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
10801902194050ARROWTELEFLEX INCORPORATEDDXE2022-11-08
10801902194067ARROWTELEFLEX INCORPORATEDDXE2022-11-08
10801902194074ARROWTELEFLEX INCORPORATEDDXE2022-11-08
10801902194081ARROWTELEFLEX INCORPORATEDDXE2022-11-08
10801902194098ARROWTELEFLEX INCORPORATEDDXE2022-11-08
10801902194104ARROWTELEFLEX INCORPORATEDDXE2022-11-08
10801902196610ARROWTELEFLEX INCORPORATEDDXE2022-11-08
20801902194040ARROWTELEFLEX INCORPORATEDDXE2022-11-08
20801902194057ARROWTELEFLEX INCORPORATEDDXE2022-11-08
20801902194064ARROWTELEFLEX INCORPORATEDDXE2022-11-08