Catalog Number

GSX0025A

Brand Name

GORE CARDIOFORM Septal Occluder

Version/Model Number

GSX0025A

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

P050006

Product Code

MLV

Product Code Name

Transcatheter Septal Occluder

Public Device Record Key

e38c5511-fc30-45ea-a260-736e8a65478c

Public Version Date

April 08, 2022

Public Version Number

7

DI Record Publish Date

February 13, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-