FDA.reportPublic FDA data

ADVANTA

Primary DI
00650862212761
Brand
ADVANTA
Company
Atrium Medical Corporation
Model
21276
Device description
4MMX10CM, 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
00650862212761PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00650862212761006508622127616508622127610650862212761

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
00733132605354GORE ACUSEAL Vascular GraftW. L. Gore & Associates, Inc.DYF2017-02-13
00733132606290GORE PROPATEN Vascular Graft Pediatric ShuntW. L. Gore & Associates, Inc.DYF2017-02-13
00733132606313GORE PROPATEN Vascular Graft Pediatric ShuntW. L. Gore & Associates, Inc.DYF2017-02-13
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
00733132615926GORE-TEX Vascular GraftW. L. Gore & Associates, Inc.DYF2017-02-13
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