FDA.reportPublic FDA data

Flair® Endovascular Stent Graft

Primary DI
04049519008844
Brand
Flair® Endovascular Stent Graft
Company
Bard Peripheral Vascular, Inc.
Model
FAF08070
Catalog number
FAF08070
Device description
FLAIR® Endovascular Stent Graft 8 mm x 70 mm (80 cm delivery catheter)(flared)
Published
2014-09-19
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
MR Conditional
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
MIHSYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
PFVSystem, endovascular graft, arteriovenous (AV) dialysis access circuit stenosis treatment

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MIHSystem, Endovascular Graft, Aortic Aneurysm TreatmentUnknown3
PFVSystem, Endovascular Graft, Arteriovenous (Av) Dialysis Access Circuit Stenosis TreatmentUnknown3

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
P060002000
P060002027
P060002034
P060002038

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P060002000FLAIR ENDOVASCULAR STENT GRAFTBard Peripheral Vascular2007-07-23PFV
P060002027FLAIR ENDOVASCULAR STENT GRAFTBard Peripheral Vascular2007-07-23PFV
P060002034FLAIR ENDOVASCULAR STENT GRAFTBard Peripheral Vascular2007-07-23PFV
P060002038FLAIR ENDOVASCULAR STENT GRAFTBard Peripheral Vascular2007-07-23PFV

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
14049519008841PackageGS11Not in Commercial Distribution
04049519008844PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1404951900884114049519008841
04049519008844040495190088444049519008844

GMDN Terms#

Term, Definition table
TermDefinition
Iliofemoral artery endovascular stent-graftA sterile non-bioabsorbable tubular device intended to be implanted in the iliac and, alternatively, superficial femoral arteries to reline tortuous arteries in patients with symptomatic peripheral vascular disease (PVD). It is percutaneously inserted via the femoral artery to the site of implantation, with a disposable delivery device, where it self-expands. It is typically made of nickel-titanium alloy (Nitinol) that forms an outer mesh structure with an inner polymer tube (endovascular graft). It is available in a variety of lengths and diameters. Disposable devices associated with implantation may be included.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Keep away from sunlight
Special Storage Condition, Specify00Keep dry
Special Storage Condition, Specify00Protect the packaged product from direct sunlight
Special Storage Condition, Specify00Store in a cool (room temperature), dry place

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)321-4254medical.services@crbard.com

Regulatory Flags#

DUNS number
135057938
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10801741234184EnCor EnCompass™ENCPBagENCPBag2026-02-09
00801741234187EnCor EnCompass™ENCPBagENCPBag2026-02-09
00801741234156EnCor EnCompass™ENCPSCENCPSC2026-02-04
00801741234163EnCor EnCompass™ENCPMRIXENCPMRIX2026-02-04
10801741234153EnCor EnCompass™ENCPSCENCPSC2026-02-04
10801741234160EnCor EnCompass™ENCPMRIXENCPMRIX2026-02-04
00801741236167EnCor EnCompass™ENCP10GVLOCENCP10GVLOC2026-02-04
00801741234194EnCor EnCompass™ENCPSTENCPST2026-02-03
00801741234248EnCor EnCompass™ENCPDriverENCPDriver2026-02-03
00801741234262EnCor EnCompass™ENCPFSENCPFS2026-02-03
00801741235221EnCor EnCompass™ENCPConsoleENCPConsole2026-02-03
00801741234095EnCor EnCompass™ENCP7GENCP7G2026-01-30
00801741234132EnCor EnCompass™ENCP7GBTENCP7GBT2026-01-30
10801741234092EnCor EnCompass™ENCP7GENCP7G2026-01-30
10801741234139EnCor EnCompass™ENCP7GBTENCP7GBT2026-01-30
00801741234200EnCor EnCompass™ENCP7GVLOCENCP7GVLOC2026-01-30
00801741234118EnCor EnCompass™ENCP12GENCP12G2026-01-28
00801741234149EnCor EnCompass™ENCP10GBTENCP10GBT2026-01-28
00801741234170EnCor EnCompass™ENCP10GENCP10G2026-01-28
10801741234115EnCor EnCompass™ENCP12GENCP12G2026-01-28

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00827002599109Zenith AlphaWilliam Cook Europe ApSMIH2024-12-03
00733132645763GORE VIABAHN EndoprosthesisW. L. Gore & Associates, Inc.PFV2019-08-16
00733132645787GORE VIABAHN EndoprosthesisW. L. Gore & Associates, Inc.PFV2019-08-16
00733132645800GORE VIABAHN EndoprosthesisW. L. Gore & Associates, Inc.PFV2019-08-16
00733132645848GORE VIABAHN EndoprosthesisW. L. Gore & Associates, Inc.PFV2019-08-16
00733132645886GORE VIABAHN EndoprosthesisW. L. Gore & Associates, Inc.PFV2019-08-16
00733132645909GORE VIABAHN EndoprosthesisW. L. Gore & Associates, Inc.PFV2019-08-16
00733132645947GORE VIABAHN Endoprosthesis with HeparinW. L. Gore & Associates, Inc.PFV2019-08-16
00733132645985GORE VIABAHN Endoprosthesis with HeparinW. L. Gore & Associates, Inc.PFV2019-08-16
00733132646029GORE VIABAHN Endoprosthesis with HeparinW. L. Gore & Associates, Inc.PFV2019-08-16
00733132646067GORE VIABAHN Endoprosthesis with HeparinW. L. Gore & Associates, Inc.PFV2019-08-16
00733132646104GORE VIABAHN Endoprosthesis with HeparinW. L. Gore & Associates, Inc.PFV2019-08-16
00733132646142GORE VIABAHN Endoprosthesis with HeparinW. L. Gore & Associates, Inc.PFV2019-08-16
00733132614431GORE VIABAHN EndoprosthesisW. L. Gore & Associates, Inc.PFV2017-03-04
00733132614479GORE VIABAHN EndoprosthesisW. L. Gore & Associates, Inc.PFV2017-03-04
00733132614493GORE VIABAHN EndoprosthesisW. L. Gore & Associates, Inc.PFV2017-03-04
00733132614516GORE VIABAHN EndoprosthesisW. L. Gore & Associates, Inc.PFV2017-03-04
00733132614554GORE VIABAHN EndoprosthesisW. L. Gore & Associates, Inc.PFV2017-03-04
00733132614578GORE VIABAHN EndoprosthesisW. L. Gore & Associates, Inc.PFV2017-03-04
00733132614615GORE VIABAHN EndoprosthesisW. L. Gore & Associates, Inc.PFV2017-03-04
00733132614639GORE VIABAHN EndoprosthesisW. L. Gore & Associates, Inc.PFV2017-03-04
00733132614653GORE VIABAHN EndoprosthesisW. L. Gore & Associates, Inc.PFV2017-03-04
00733132614769GORE VIABAHN Endoprosthesis with HeparinW. L. Gore & Associates, Inc.PFV2017-03-04
00733132614783GORE VIABAHN Endoprosthesis with HeparinW. L. Gore & Associates, Inc.PFV2017-03-04
00733132614806GORE VIABAHN Endoprosthesis with HeparinW. L. Gore & Associates, Inc.PFV2017-03-04
00733132614820GORE VIABAHN Endoprosthesis with HeparinW. L. Gore & Associates, Inc.PFV2017-03-04
00733132614844GORE VIABAHN Endoprosthesis with HeparinW. L. Gore & Associates, Inc.PFV2017-03-04
00733132614868GORE VIABAHN Endoprosthesis with HeparinW. L. Gore & Associates, Inc.PFV2017-03-04
00733132614882GORE VIABAHN Endoprosthesis with HeparinW. L. Gore & Associates, Inc.PFV2017-03-04
00733132614936GORE VIABAHN Endoprosthesis with HeparinW. L. Gore & Associates, Inc.PFV2017-03-04