FDA.reportPublic FDA data

AlboGraft Polyester Vascular Graft

Primary DI
00840663104086
Brand
AlboGraft Polyester Vascular Graft
Company
Lemaitre Vascular, Inc.
Model
ATC9034
Catalog number
ATC9034
Device description
AlboGraft Polyester Vascular Graft 90cmx34mm
Published
2015-11-09
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
MALGraft, Vascular, Synthetic/Biologic Composite

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MALGraft, Vascular, Synthetic/Biologic CompositeCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K093231000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K093231000ALBOGRAFT VASCULAR PROSTHESISLeMaitre Vascular, Inc.2010-01-14MAL

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840663104086PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840663104086008406631040868406631040860840663104086

GMDN Terms#

Term, Definition table
TermDefinition
Synthetic vascular graftA sterile artificial substitute for a blood vessel intended to replace or bypass the diseased or injured vessel. It is typically made of woven or knitted polyethylene terephthalate (Dacron) or polytetrafluoroethylene (PTFE) fabrics and is best suited for large (more than 10 mm) diameter, high-flow vessel replacement (e.g., aortic or aorto-iliac artery reconstruction) and also for haemodialysis access and extra-anatomic bypass grafting. The device is used in many vascular bypass procedures (e.g., aorto-iliac, femoral-popliteal, axillo-axillary artery) except those involving the coronary arteries.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
7812212266csus@lemaitre.com

Regulatory Flags#

DUNS number
184805166
Device count
1
Lot or batch
true
Serial number
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00840663102297Eze-Sit Valvulotome94cmTIVK20302022-06-30
00840663100095Expandable LeMaitre Valvulotome1000-901000-902015-06-30
00840663100101Expandable LeMaitre Valvulotomee1000-90e1000-902015-06-30
00840663100118Expandable LeMaitre Valvulotome1000-951000-952015-06-30
00840663100132Over-the-Wire LeMaitre Valvulotome1005-001005-002015-06-30
00840663100149Over-the-Wire LeMaitre Valvulotomee1005-00e1005-002015-06-30
00840663100163Over-the-Wire LeMaitre Valvulotome1006-001006-002015-06-30
00840663100309Expandable LeMaitre Valvulotome1096-001096-002015-06-30
00840663106653HYDRO LeMaitre Valvulotome1009-001009-002015-06-30
00840663106660HYDRO LeMaitre Valvulotome1010-001010-002015-06-30
00840663106721Expandable LeMaitre Valvulotomee1096-00e1096-002015-07-15
00840663106820Hydro LeMaitre Valvulotomee1009-00e1009-002015-07-15
00840663106837Hydro LeMaitre Valvulotomee1010-00e1010-002015-07-15
00840663107315Retrograde LeMills Valvulotome1050-001050-002015-06-30
00840663107322Antegrade LeMills Valvulotome1050-011050-012015-06-30
00840663107339Antegrade and Retrograde LeMills Valvulotome1050-021050-022015-06-30
00840663107346Retrograde LeMills Valvulotomee1050-00e1050-002015-06-30
00840663107353Antegrade LeMills Valvulotomee1050-01e1050-012015-06-30
00840663107360Antegrade and Retrograde LeMills Valvulotomee1050-02e1050-022015-06-30
00840663110360AlboGraft Polyester Vascular Graft ATC6034ATC60342021-06-18

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840663110353AlboGraft Polyester Vascular GraftLemaitre Vascular, Inc.MAL2021-06-18
00840663110360AlboGraft Polyester Vascular Graft Lemaitre Vascular, Inc.MAL2021-06-18
00840663110377AlboGraft Polyester Vascular Graft Lemaitre Vascular, Inc.MAL2021-06-18
00840663110384AlboGraft Polyester Vascular Graft Lemaitre Vascular, Inc.MAL2021-06-18
00840663110391AlboGraft Polyester Vascular GraftLemaitre Vascular, Inc.MAL2021-06-18
00840663110407AlboGraft Polyester Vascular GraftLemaitre Vascular, Inc.MAL2021-06-18
00840663110414AlboGraft Polyester Vascular GraftLemaitre Vascular, Inc.MAL2021-06-18
00840663110421AlboGraft Polyester Vascular GraftLemaitre Vascular, Inc.MAL2021-06-18
00840663110438AlboGraft Polyester Vascular GraftLemaitre Vascular, Inc.MAL2021-06-18
00840663110445AlboGraft Polyester Vascular GraftLemaitre Vascular, Inc.MAL2021-06-18
00840663107384AlboGraft Polyester Vascular Graft Lemaitre Vascular, Inc.MAL2015-12-29
00840663107407AlboGraft Polyester Vascular Graft Lemaitre Vascular, Inc.MAL2015-12-29
00840663103935AlboGraft Polyester Vascular Graft Lemaitre Vascular, Inc.MAL2015-11-09
00840663103942AlboGraft Polyester Vascular Graft Lemaitre Vascular, Inc.MAL2015-11-09
00840663103959AlboGraft Polyester Vascular Graft Lemaitre Vascular, Inc.MAL2015-11-09
00840663103966AlboGraft Polyester Vascular Graft Lemaitre Vascular, Inc.MAL2015-11-09
00840663103973AlboGraft Polyester Vascular Graft Lemaitre Vascular, Inc.MAL2015-11-09
00840663103980AlboGraft Polyester Vascular Graft Lemaitre Vascular, Inc.MAL2015-11-09
00840663103997AlboGraft Polyester Vascular Graft Lemaitre Vascular, Inc.MAL2015-11-09
00840663104000AlboGraft Polyester Vascular Graft Lemaitre Vascular, Inc.MAL2015-11-09
00840663104017AlboGraft Polyester Vascular Graft Lemaitre Vascular, Inc.MAL2015-11-09
00840663104024AlboGraft Polyester Vascular Graft Lemaitre Vascular, Inc.MAL2015-11-09
00840663104031AlboGraft Polyester Vascular Graft Lemaitre Vascular, Inc.MAL2015-11-09
00840663104048AlboGraft Polyester Vascular Graft Lemaitre Vascular, Inc.MAL2015-11-09
00840663104055AlboGraft Polyester Vascular Graft Lemaitre Vascular, Inc.MAL2015-11-09
00840663104062AlboGraft Polyester Vascular Graft Lemaitre Vascular, Inc.MAL2015-11-09
00840663104079AlboGraft Polyester Vascular Graft Lemaitre Vascular, Inc.MAL2015-11-09
00840663104093AlboGraft Polyester Vascular Graft Lemaitre Vascular, Inc.MAL2015-11-09
00840663104109AlboGraft Polyester Vascular Graft Lemaitre Vascular, Inc.MAL2015-11-09
00840663104147AlboGraft Polyester Vascular Graft Lemaitre Vascular, Inc.MAL2015-11-09