Catalog Number

-

Brand Name

JETi Thrombectomy System, Sterile Disposable Components Kit, 6 Fr

Version/Model Number

WV6203-1

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

November 15, 2021

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

-

Product Code Name

-

Public Device Record Key

1ab13a1f-67f7-44b6-835e-3e4b1c293b37

Public Version Date

September 27, 2022

Public Version Number

3

DI Record Publish Date

June 17, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-