Catalog Number

WV0006-01

Brand Name

JETi Peripheral Catheter

Version/Model Number

WV0006-01

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

January 18, 2018

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

366b5b7b-1a42-4453-92d7-7962eea3e9c2

Public Version Date

September 27, 2022

Public Version Number

6

DI Record Publish Date

July 17, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-