ADVANTA

Primary DI
00650862212778
Brand
ADVANTA
Company
Atrium Medical Corporation
Model
21277
Device description
5MMX10CM, SW, ADVANTA VXT
Published
2015-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
DYFPROSTHESIS, VASCULAR GRAFT, OF LESS THEN 6MM DIAMETER

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DYFProsthesis, Vascular Graft, Of Less Then 6mm DiameterCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K231972000
K992958000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K231972000Advanta VXT Vascular Graft, Flixene Vascular GraftAtrium Medical Corporation2024-03-28DSY
K992958000ADVANTA GRAFT (<6MM)Atrium Medical Corp.1999-10-01DYF

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00650862212778PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00650862212778006508622127786508622127780650862212778

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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Humidity0 Percent (%) Relative Humidity80 Percent (%) Relative Humidity
Storage Environment Temperature59 Degrees Fahrenheit77 Degrees Fahrenheit

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
051798999
Device count
1
Serial number
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00650862122916iCast covered stent system, 12mm x 29mm x 80cmGBX12291A2026-02-18
00650862122923iCast covered stent system, 12mm x 29mm x 120cmGBX12292A2026-02-18
00650862124118iCast covered stent system, 12mm x 41mm x 80cmGBX12411A2026-02-18
00650862124125iCast covered stent system, 12mm x 41mm x 120cmGBX12412A2026-02-18
00650862126112iCast covered stent system, 12mm x 61mm x 80cmGBX12611A2026-02-18
00650862126129iCast covered stent system, 12mm x 61mm x 120cmGBX12612A2026-02-18
00650862425321iCast covered stent system, 5mm x 32mm x 120cm425322026-02-18
00650862426328iCast covered stent system, 6mm x 32mm x 120cm 426322026-02-18
00650862427325iCast covered stent system, 7mm x 32mm x 120cm427322026-02-18
00650862428322iCast covered stent system, 8mm x 32mm x 120cm428322026-02-18
00650862429329iCast covered stent system, 9mm x 32mm x 120cm429322026-02-18
00650862480597iCast covered stent system, 10mm x 59mm x 80cm480592026-02-18
00650862485325iCast covered stent system, 5mm x 32mm x 80cm485322026-02-18
00650862486322iCast covered stent system, 6mm x 32mm x 80cm 486322026-02-18
00650862487329iCast covered stent system, 7mm x 32mm x 80cm 487322026-02-18
00650862488326iCast covered stent system, 8mm x 32mm x 80cm 488322026-02-18
00650862489323iCast covered stent system, 9mm x 32mm x 80cm489322026-02-18
00650862720594iCast covered stent system, 10mm x 59mm x 120cm720592026-02-18
00650862420388iCast Covered Stent System, 10mmX38mmX120cm42038420382023-06-09
00650862425161iCast Covered Stent System, 5mmX16mmX120cm42516425162023-06-09

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00733132606351GORE PROPATEN Vascular Graft Pediatric ShuntW. L. Gore & Associates, Inc.DYF2017-02-13
00733132606375GORE PROPATEN Vascular Graft Pediatric ShuntW. L. Gore & Associates, Inc.DYF2017-02-13
00733132606399GORE PROPATEN Vascular Graft Pediatric ShuntW. L. Gore & Associates, Inc.DYF2017-02-13
00733132606436GORE PROPATEN Vascular Graft Pediatric ShuntW. L. Gore & Associates, Inc.DYF2017-02-13
00733132607068GORE PROPATEN Vascular GraftW. L. Gore & Associates, Inc.DYF2017-02-13
00733132607129GORE PROPATEN Vascular GraftW. L. Gore & Associates, Inc.DYF2017-02-13
00733132607143GORE PROPATEN Vascular GraftW. L. Gore & Associates, Inc.DYF2017-02-13
00733132613960GORE-TEX Vascular GraftW. L. Gore & Associates, Inc.DYF2017-02-13
00733132613977GORE-TEX Vascular GraftW. L. Gore & Associates, Inc.DYF2017-02-13
00733132613984GORE-TEX Vascular GraftW. L. Gore & Associates, Inc.DYF2017-02-13
00733132613991GORE-TEX Vascular GraftW. L. Gore & Associates, Inc.DYF2017-02-13
00733132614004GORE-TEX Vascular GraftW. L. Gore & Associates, Inc.DYF2017-02-13
00733132614011GORE-TEX Vascular GraftW. L. Gore & Associates, Inc.DYF2017-02-13
00733132614028GORE-TEX Vascular GraftW. L. Gore & Associates, Inc.DYF2017-02-13
00733132614035GORE-TEX Vascular GraftW. L. Gore & Associates, Inc.DYF2017-02-13
00733132614073GORE-TEX Vascular GraftW. L. Gore & Associates, Inc.DYF2017-02-13
00733132614080GORE-TEX Vascular GraftW. L. Gore & Associates, Inc.DYF2017-02-13
00733132614110GORE-TEX Vascular GraftW. L. Gore & Associates, Inc.DYF2017-02-13
00733132614165GORE-TEX Vascular GraftW. L. Gore & Associates, Inc.DYF2017-02-13
00733132614172GORE-TEX Vascular GraftW. L. Gore & Associates, Inc.DYF2017-02-13
00733132615872GORE-TEX Vascular GraftW. L. Gore & Associates, Inc.DYF2017-02-13
00733132615889GORE-TEX Vascular GraftW. L. Gore & Associates, Inc.DYF2017-02-13
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00733132615933GORE-TEX Vascular GraftW. L. Gore & Associates, Inc.DYF2017-02-13
00733132615940GORE-TEX Vascular GraftW. L. Gore & Associates, Inc.DYF2017-02-13
00733132615957GORE-TEX Vascular GraftW. L. Gore & Associates, Inc.DYF2017-02-13
00733132615988GORE-TEX Vascular GraftW. L. Gore & Associates, Inc.DYF2017-02-13