FDA.reportPublic FDA data

GORE-TEX Vascular Graft Pediatric Shunt

Primary DI
H373VT04010LA3
Brand
GORE-TEX Vascular Graft Pediatric Shunt
Company
W. L. Gore & Associates, Inc.
Model
VT04010LA
Catalog number
VT04010LA
Device description
VG T4MM X 10CM SILK
Published
2017-02-13
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
DSYPROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DSYProsthesis, Vascular Graft, Of 6mm And Greater DiameterCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K013250000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K013250000GORE-TEX VASCULAR GRAFT; GORE-TEX STRETCH VASCULAR GRAFTW. L. Gore & Associates, Inc.2001-10-26DSY

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00733132615865PrimaryGS10
H373VT04010LA3SecondaryHIBCC0

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00733132615865007331326158657331326158650733132615865

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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length10Centimeter
Lumen/Inner Diameter4Millimeter

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)528-8763mpdcustomercare@wlgore.com

Regulatory Flags#

DUNS number
967358115
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00733132606290GORE PROPATEN Vascular Graft Pediatric ShuntHPT040015AHPT040015A2017-02-13
00733132606313GORE PROPATEN Vascular Graft Pediatric ShuntHPT050005AHPT050005A2017-02-13
00733132606351GORE PROPATEN Vascular Graft Pediatric ShuntHPT050015AHPT050015A2017-02-13
00733132606375GORE PROPATEN Vascular Graft Pediatric ShuntHPT060015AHPT060015A2017-02-13
00733132606399GORE PROPATEN Vascular Graft Pediatric ShuntHPT350005AHPT350005A2017-02-13
00733132606436GORE PROPATEN Vascular Graft Pediatric ShuntHPT350015AHPT350015A2017-02-13
00733132607068GORE PROPATEN Vascular GraftIRH060545AIRH060545A2017-02-13
00733132607129GORE PROPATEN Vascular GraftIRH463845AIRH463845A2017-02-13
00733132607143GORE PROPATEN Vascular GraftIRH473845AIRH473845A2017-02-13
00733132653690GORE SYNECOR Preperitoneal BiomaterialGKWR4040GKWR40402022-11-08
00733132653706GORE SYNECOR Preperitoneal BiomaterialGKWR3030GKWR30302022-11-08
00733132653713GORE SYNECOR Preperitoneal BiomaterialGKWR4050GKWR40502022-11-08
00733132653720GORE SYNECOR Preperitoneal BiomaterialGKWR3535GKWR35352022-11-08
00733132653737GORE SYNECOR Preperitoneal BiomaterialGKWR3040GKWR30402022-11-08
00733132653744GORE SYNECOR Preperitoneal BiomaterialGKWC09GKWC092021-10-05
00733132605798GORE PROPATEN Vascular GraftH060010AH060010A2017-02-13
00733132605811GORE PROPATEN Vascular GraftH060040AH060040A2017-02-13
00733132605835GORE PROPATEN Vascular GraftH060060AH060060A2017-02-13
00733132605859GORE PROPATEN Vascular GraftH060080AH060080A2017-02-13
00733132605873GORE PROPATEN Vascular GraftH080040AH080040A2017-02-13

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
05037881184883Gelweave Vascular ProsthesesVASCUTEK LTDDSY2026-05-22
05037881184890Gelweave Vascular ProsthesesVASCUTEK LTDDSY2026-05-22
05037881184906Gelweave Vascular ProsthesesVASCUTEK LTDDSY2026-05-22
05037881184913Gelweave Vascular ProsthesesVASCUTEK LTDDSY2026-05-22
05037881184920Gelweave Vascular ProsthesesVASCUTEK LTDDSY2026-05-22
05037881184937Gelweave Vascular ProsthesesVASCUTEK LTDDSY2026-05-22
00733132600038GORE Hybrid Vascular Graft-CBASW. L. Gore & Associates, Inc.DSY2017-02-13
00733132600052GORE Hybrid Vascular Graft-CBASW. L. Gore & Associates, Inc.DSY2017-02-13
00733132600076GORE Hybrid Vascular Graft-CBASW. L. Gore & Associates, Inc.DSY2017-02-13
00733132600090GORE Hybrid Vascular Graft-CBASW. L. Gore & Associates, Inc.DSY2017-02-13
00733132605354GORE ACUSEAL Vascular GraftW. L. Gore & Associates, Inc.DSY2017-02-13
00733132606290GORE PROPATEN Vascular Graft Pediatric ShuntW. L. Gore & Associates, Inc.DSY2017-02-13
00733132606313GORE PROPATEN Vascular Graft Pediatric ShuntW. L. Gore & Associates, Inc.DSY2017-02-13
00733132606351GORE PROPATEN Vascular Graft Pediatric ShuntW. L. Gore & Associates, Inc.DSY2017-02-13
00733132606375GORE PROPATEN Vascular Graft Pediatric ShuntW. L. Gore & Associates, Inc.DSY2017-02-13
00733132606399GORE PROPATEN Vascular Graft Pediatric ShuntW. L. Gore & Associates, Inc.DSY2017-02-13
00733132606436GORE PROPATEN Vascular Graft Pediatric ShuntW. L. Gore & Associates, Inc.DSY2017-02-13
00733132607068GORE PROPATEN Vascular GraftW. L. Gore & Associates, Inc.DSY2017-02-13
00733132607129GORE PROPATEN Vascular GraftW. L. Gore & Associates, Inc.DSY2017-02-13
00733132607143GORE PROPATEN Vascular GraftW. L. Gore & Associates, Inc.DSY2017-02-13
00733132607150GORE INTERING Vascular GraftW. L. Gore & Associates, Inc.DSY2017-02-13
00733132607174GORE INTERING Vascular GraftW. L. Gore & Associates, Inc.DSY2017-02-13
00733132607181GORE INTERING Vascular GraftW. L. Gore & Associates, Inc.DSY2017-02-13
00733132607211GORE INTERING Vascular GraftW. L. Gore & Associates, Inc.DSY2017-02-13
00733132607228GORE INTERING Vascular GraftW. L. Gore & Associates, Inc.DSY2017-02-13
00733132607235GORE INTERING Vascular GraftW. L. Gore & Associates, Inc.DSY2017-02-13
00733132607242GORE INTERING Vascular GraftW. L. Gore & Associates, Inc.DSY2017-02-13
00733132607259GORE INTERING Vascular GraftW. L. Gore & Associates, Inc.DSY2017-02-13
00733132607266GORE INTERING Vascular GraftW. L. Gore & Associates, Inc.DSY2017-02-13
00733132607273GORE INTERING Vascular GraftW. L. Gore & Associates, Inc.DSY2017-02-13