JETi Thrombectomy System, Sterile Disposable Compo

GUDID B139WV600312

WALK VASCULAR L.L.C.

Thrombectomy suction catheter
Primary Device IDB139WV600312
NIH Device Record Key825eb94d-de19-4d04-b703-c736723fcf87
Commercial Distribution StatusIn Commercial Distribution
Brand NameJETi Thrombectomy System, Sterile Disposable Compo
Version Model NumberWV6003-1
Company DUNS034774488
Company NameWALK VASCULAR L.L.C.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Dimensions

Catheter Length120 Centimeter
Catheter Gauge6 French
Catheter Length120 Centimeter
Catheter Gauge6 French
Catheter Length120 Centimeter
Catheter Gauge6 French
Catheter Length120 Centimeter
Catheter Gauge6 French
Catheter Length120 Centimeter
Catheter Gauge6 French
Catheter Length120 Centimeter
Catheter Gauge6 French
Catheter Length120 Centimeter
Catheter Gauge6 French
Catheter Length120 Centimeter
Catheter Gauge6 French
Catheter Length120 Centimeter
Catheter Gauge6 French
Catheter Length120 Centimeter
Catheter Gauge6 French
Catheter Length120 Centimeter
Catheter Gauge6 French
Catheter Length120 Centimeter
Catheter Gauge6 French
Catheter Length120 Centimeter
Catheter Gauge6 French
Catheter Length120 Centimeter
Catheter Gauge6 French
Catheter Length120 Centimeter
Catheter Gauge6 French
Catheter Length120 Centimeter
Catheter Gauge6 French
Catheter Length120 Centimeter
Catheter Gauge6 French
Catheter Length120 Centimeter
Catheter Gauge6 French
Catheter Length120 Centimeter
Catheter Gauge6 French

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCB139WV600311 [Primary]
HIBCCB139WV600312 [Package]
Contains: B139WV600311
Package: Corrugated Box [5 Units]
In Commercial Distribution

Sterilization

Steralize Prior To Usetrue
Device Is Steriletrue

[B139WV600312]

Ethylene Oxide


[B139WV600312]

Ethylene Oxide


[B139WV600312]

Ethylene Oxide


[B139WV600312]

Ethylene Oxide


[B139WV600312]

Ethylene Oxide


[B139WV600312]

Ethylene Oxide


[B139WV600312]

Ethylene Oxide


[B139WV600312]

Ethylene Oxide


[B139WV600312]

Ethylene Oxide


[B139WV600312]

Ethylene Oxide


[B139WV600312]

Ethylene Oxide


[B139WV600312]

Ethylene Oxide


[B139WV600312]

Ethylene Oxide


[B139WV600312]

Ethylene Oxide


[B139WV600312]

Ethylene Oxide


[B139WV600312]

Ethylene Oxide


[B139WV600312]

Ethylene Oxide


[B139WV600312]

Ethylene Oxide


[B139WV600312]

Ethylene Oxide


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-03-11
Device Publish Date2019-02-08

On-Brand Devices [JETi Thrombectomy System, Sterile Disposable Compo]

B139WV800311WV8003-1
B139WV80031WV8003
B139WV600312WV6003-1
B139WV60032WV6003

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.