Flair® Endovascular Stent Graft - FLAIR® Endovascular Stent Graft 6 mm x 30 mm (80 - Bard Peripheral Vascular, Inc.

Duns Number:135057938

Device Description: FLAIR® Endovascular Stent Graft 6 mm x 30 mm (80 cm delivery catheter)(straight)

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More Product Details

Catalog Number

FAS06030

Brand Name

Flair® Endovascular Stent Graft

Version/Model Number

FAS06030

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

May 10, 2022

Issuing Agency

In GS1

Product Characteristics

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

P060002,P060002,P060002,P060002,P060002,P060002,P060002,P060002,P060002,P060002,P060002,P060002,P060002,P060002

Product Code Details

Product Code

PFV

Product Code Name

System, endovascular graft, arteriovenous (AV) dialysis access circuit stenosis treatment

Device Record Status

Public Device Record Key

6653ac8a-7ed0-44f1-8bcb-c1227dd7d265

Public Version Date

June 15, 2022

Public Version Number

6

DI Record Publish Date

September 19, 2014

Additional Identifiers

Package DI Number

14049519008896

Quantity per Package

1

Contains DI Package

04049519008899

Package Discontinue Date

May 10, 2022

Package Status

Not in Commercial Distribution

Package Type

Other

"BARD PERIPHERAL VASCULAR, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 35
2 A medical device with a moderate to high risk that requires special controls. 2835
3 A medical device with high risk that requires premarket approval 190