Catalog Number

FREDX4013

Brand Name

Stent

Version/Model Number

FREDX4013-PMA

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

P180027

Product Code

OUT

Product Code Name

Intracranial aneurysm flow diverter

Public Device Record Key

8c6fbe9f-935b-4d57-a15f-344bc4fc599b

Public Version Date

October 10, 2022

Public Version Number

2

DI Record Publish Date

April 11, 2022

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-