Catalog Number

V058010

Brand Name

Venos Occlusion Balloon Catheter

Version/Model Number

V058010

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

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

K081052

Product Code

DYG

Product Code Name

CATHETER, FLOW DIRECTED

Public Device Record Key

808f0b97-4a06-4a0c-b43a-bf824f3ba892

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

November 30, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-