FDA.report

JETi™

Primary DI
08717648353291
Company
ABBOTT VASCULAR INC.
Model
WV062F
Catalog number
WV062F
Device description
JETi™ 6F Catheter
Published
2023-03-31
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Related Records

Regulatory Flags

DUNS number
964569052
Device count
1
DM exempt
true
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
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

Identifiers

IdentifierTypeAgencyPackage quantityStatus
08717648353291PrimaryGS10

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityPackage typeContains DIDiscontinue dateStatus
08717648353291PrimaryGS10

Product Codes

CodeNameClassSpecialtyRegulationImplantMalfunction reporting
QEZAspiration Thrombectomy Catheter2Cardiovascular870.5150NEligible

Premarket Submissions

No records found.

Premarket Details

No records found.

GMDN Terms

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

No records found.

Storage And Handling

TypeLowHighCondition
Handling Environment Humidity10 Percent (%) Relative Humidity95 Percent (%) Relative Humidity
Handling Environment Temperature-30 Degrees Celsius60 Degrees Celsius
Special Storage Condition, Specify00Store in a dry and dark place between 15°C – 25°C (59°F – 77°F) with excursions permitted.
Storage Environment Temperature15 Degrees Celsius25 Degrees Celsius

Sterilization Methods

Method

Contacts

PhoneEmail
+1(800)227-9902av.customercare@av.abbott.com

Other Devices From This Company

Primary DIBrandModelCatalogPublished
08717648353765Esprit™Esprit™1212375-282025-07-12
08717648353666Esprit™Esprit™1212350-182025-07-10
08717648353680Esprit™Esprit™1212350-282025-07-10
08717648353703Esprit™Esprit™1212350-382025-07-10
08717648353741Esprit™Esprit™ 1212375-182025-07-10
08717648353789Esprit™Esprit™1212375-382025-07-10
08717648353826Esprit™Esprit™1212250-182025-07-10
08717648353840Esprit™Esprit™1212250-282025-07-10
08717648353864Esprit™Esprit™1212250-382025-07-10
08717648353987Esprit™Esprit™1212300-182025-07-10
08717648354007Esprit™Esprit™1212300-282025-07-10
08717648354021Esprit™Esprit™1212300-382025-07-10
08717648356704XACT™83024-0183024-012025-04-17
08717648356742XACT™ 83022-0183022-012025-04-17
08717648356766XACT™83020-0183020-012025-04-17
08717648356803XACT™83026-0183026-012025-04-17
08717648356810HI-TORQUE COMMAND™ 106000110600012024-11-21
08717648356827HI-TORQUE COMMAND™ 1060001A1060001A2024-11-21
08717648356834HI-TORQUE COMMAND™106000210600022024-11-21
08717648356841HI-TORQUE COMMAND™ 1060002A1060002A2024-11-21

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
B090P110901VentiV ScientificZIEN MEDICAL TECHNOLOGIES, INC.QEZ2025-11-24
B090P11090F1VentiV ScientificZIEN MEDICAL TECHNOLOGIES, INC.QEZ2025-11-24
20841156110489PRONTOTELEFLEX INCORPORATEDQEZ2025-09-17
20841156110472PRONTOTELEFLEX INCORPORATEDQEZ2025-08-25
20841156110496PRONTOTELEFLEX INCORPORATEDQEZ2025-03-18
00813132029869QuickClearPhilips Image Guided Therapy CorporationQEZ2023-06-09
B090ASP10131Control 7F Mechanical Thrombectomy SystemZIEN MEDICAL TECHNOLOGIES, INC.QEZ2023-05-03
B090ASP10211Control 11F Mechanical Thrombectomy SystemZIEN MEDICAL TECHNOLOGIES, INC.QEZ2023-05-03
B090ASP10331Control 7F Mechanical Thrombectomy SystemZIEN MEDICAL TECHNOLOGIES, INC.QEZ2023-05-03
B090ASP10361Control 11F Mechanical Thrombectomy SystemZIEN MEDICAL TECHNOLOGIES, INC.QEZ2023-05-03
B090ASP10011Control RX-LP Mechanical Thrombectomy SystemZIEN MEDICAL TECHNOLOGIES, INC.QEZ2023-04-26
08717648353260JETi™ABBOTT VASCULAR INC.QEZ2023-03-31
08717648353277JETi™ABBOTT VASCULAR INC.QEZ2023-03-31
08717648353284JETi™ABBOTT VASCULAR INC.QEZ2023-03-31
B090A110601Control 11F Mechanical Thrombectomy System, 60cmZIEN MEDICAL TECHNOLOGIES, INC.QEZ2022-06-29
B090A110901Control 11F Mechanical Thrombectomy SystemZIEN MEDICAL TECHNOLOGIES, INC.QEZ2022-06-29
B090A70600Control 7F Mechanical Thrombectomy SystemZIEN MEDICAL TECHNOLOGIES, INC.QEZ2022-06-29
B090A70901Control 7F Mechanical Thrombectomy SystemZIEN MEDICAL TECHNOLOGIES, INC.QEZ2022-06-29
B090A90601Control 9F Mechanical Thrombectomy System, 60cmZIEN MEDICAL TECHNOLOGIES, INC.QEZ2022-06-29
B090A90901Control 9F Mechanical Thrombectomy System, 90cmZIEN MEDICAL TECHNOLOGIES, INC.QEZ2022-06-29
H787253020AlphaVacAngiodynamics, Inc.QEZ2022-04-12
15051684025966AlphaVacANGIODYNAMICS, INC.QEZ2022-04-12
10884450568382ASAP®Merit Medical Systems, Inc.QEZ2022-03-04
10884450555122ASAPLP™Merit Medical Systems, Inc.QEZ2022-02-28
00845225003104QuickClear Aspiration Catheter, 8F x 85cm StraightVOLCANO ATHEROMED, INC.QEZ2022-01-19
08717648351365JETi All In One Saline Drive UnitWALK VASCULAR L.L.C.QEZ2021-12-08
08717648351372JETi All In One Accessory CartWALK VASCULAR L.L.C.QEZ2021-12-08
08717648351389JETi All In One Non-Sterile KitWALK VASCULAR L.L.C.QEZ2021-12-08
08717648351396JETi All In One Sterile Kit - 6FrWALK VASCULAR L.L.C.QEZ2021-12-08
08717648351402JETi All In One Sterile Kit - 8FrWALK VASCULAR L.L.C.QEZ2021-12-08