FDA.reportPublic FDA data

AlboGraft Polyester Vascular Graft

Primary DI
00840663110353
Brand
AlboGraft Polyester Vascular Graft
Company
Lemaitre Vascular, Inc.
Model
ATC6032
Catalog number
ATC6032
Device description
AlboGraft® Woven with Collagen 32mm x 60cm
Published
2021-06-18
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
MR Safe
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
K103080000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K103080000ALBOGRAFT VASCULAR PROSTHESISLeMaitre Vascular, Inc.2011-01-19MAL

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840663110353PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840663110353008406631103538406631103530840663110353

GMDN Terms#

Term, Definition table
TermDefinition
Synthetic vascular graftAn implantable 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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Keep away from sunlight
Special Storage Condition, Specify00keep dry
Storage Environment Temperature0 Degrees Celsius30 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
781-221-2266csus@lemaitre.com

Regulatory Flags#

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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00840663110360AlboGraft Polyester Vascular Graft ATC6034ATC60342021-06-18
00840663110377AlboGraft Polyester Vascular Graft ATC6038ATC60382021-06-18
00840663110384AlboGraft Polyester Vascular Graft ATC1206ATC12062021-06-18
00840663102815AlboGraft Polyester Vascular GraftAMC1506AMC15062015-07-30
00840663102839AlboGraft Polyester Vascular Graft AMC4006AMC40062015-10-16
00840663102846AlboGraft Polyester Vascular GraftAMC6006AMC60062015-10-16
00840663102853AlboGraft Polyester Vascular GraftAMC1006AMC10062015-10-16
00840663102860AlboGraft Polyester Vascular GraftAMC4007AMC40072015-10-16
00840663102877AlboGraft Polyester Vascular GraftAMC1508AMC15082015-10-16
00840663102884AlboGraft Polyester Vascular GraftAMC3008AMC30082015-10-16
00840663102891AlboGraft Polyester Vascular Graft AMC4008AMC40082015-10-16
00840663102907AlboGraft Polyester Vascular Graft AMC6007AMC60072015-10-16
00840663102914AlboGraft Polyester Vascular Graft AMC6008AMC60082015-10-16
00840663102921AlboGraft Polyester Vascular Graft AMC1008AMC10082015-10-16
00840663102938AlboGraft Polyester Vascular Graft AMC1510AMC15102015-10-16
00840663102945AlboGraft Polyester Vascular Graft AMC3010AMC30102015-10-16
00840663102952AlboGraft Polyester Vascular Graft AMC4010AMC40102015-10-16
00840663102969AlboGraft Polyester Vascular Graft AMC6010AMC60102015-10-16
00840663102976AlboGraft Polyester Vascular Graft AMC1010AMC10102015-10-16
00840663102983AlboGraft Polyester Vascular Graft AMC1512AMC15122015-10-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
00840663104086AlboGraft 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