Catalog Number

MOB37

Brand Name

GORE Molding Occlusion Balloon Catheter

Version/Model Number

MOB37

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

MR Conditional

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

K172567

Product Code

MJN

Product Code Name

Catheter, Intravascular Occluding, Temporary

Public Device Record Key

4f829ae6-9843-4828-84f9-6ee9b866d7ea

Public Version Date

July 08, 2022

Public Version Number

4

DI Record Publish Date

August 13, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-