Catalog Number

VT35005LA

Brand Name

GORE-TEX Vascular Graft Pediatric Shunt

Version/Model Number

VT35005LA

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

K013250

Product Code

DSY

Product Code Name

PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER

Public Device Record Key

3e3d6a30-7d58-4af1-aeda-c0b2d05aa351

Public Version Date

February 05, 2021

Public Version Number

5

DI Record Publish Date

February 13, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-