Catalog Number

-

Brand Name

JETi Thrombectomy System, Sterile Disposable Components Kit, 8Fr

Version/Model Number

WV8003

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

November 18, 2020

Issuing Agency

In HIBCC

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

Yes

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code

DXE

Product Code Name

Catheter, Embolectomy

Public Device Record Key

50b0371b-fd36-47f6-9973-5d0fd7168cd3

Public Version Date

September 27, 2022

Public Version Number

3

DI Record Publish Date

May 15, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-