Catalog Number

QT46040

Brand Name

LifeSpan Quick Tapered ePTFE Vascular Graft

Version/Model Number

QT46040

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

MR Safe

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

K130016

Product Code

DSY

Product Code Name

Prosthesis, Vascular Graft, Of 6mm And Greater Diameter

Public Device Record Key

e9dce375-aa82-43fb-97cb-b6b16ccdf849

Public Version Date

June 28, 2021

Public Version Number

1

DI Record Publish Date

June 18, 2021

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-