FDA.reportPublic FDA data

GORE CARDIOFORM ASD Occluder

Primary DI
00733132636518
Brand
GORE CARDIOFORM ASD Occluder
Company
W. L. Gore & Associates, Inc.
Model
ASD44A
Catalog number
ASD44A
Device description
GORE CARDIOFORM ASD Occluder 44 mm 10Fr
Published
2019-07-03
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
MLVTranscatheter Septal Occluder

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MLVTranscatheter Septal OccluderUnknown3

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
P050006071

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P050006071GORE HELEX SEPTAL OCCLUDERW. L. Gore & Associates, Inc.2006-08-11MLV

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00733132636518PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00733132636518007331326365187331326365180733132636518

GMDN Terms#

Term, Definition table
TermDefinition
Cardiac occluderA sterile, disk-like, device used for the non-surgical closure of cardiac defects. The device is typically self-expandable and made of wire mesh [e.g., nickel-titanium alloy (Nitinol)], and possibly additional materials (e.g., polyester). It is implanted using a dedicated catheter/sheath and delivery cable. The device is used to treat cardiac disorders that may include, but not limited to; an atrial septal defect (ASD), a ventricular septal defect (VSD), patent foramen ovale (PFO), or patent ductus arteriosus (PDA). This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Outer Diameter44Millimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature15 Degrees Celsius30 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
8005288763mpdcustomercare@wlgore.com

Regulatory Flags#

DUNS number
967358115
Device count
1
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
00733132658855GORE® DrySeal Flex Introducer SheathGDSF1033GDSF10332024-12-02
00733132658862GORE® DrySeal Flex Introducer SheathGDSF1045GDSF10452024-12-02
00733132658879GORE® DrySeal Flex Introducer SheathGDSF1065GDSF10652024-12-02
00733132658886GORE® DrySeal Flex Introducer SheathGDSF1133GDSF11332024-12-02
00733132658893GORE® DrySeal Flex Introducer SheathGDSF1233GDSF12332024-12-02
00733132658909GORE® DrySeal Flex Introducer SheathGDSF1245GDSF12452024-12-02
00733132658916GORE® DrySeal Flex Introducer SheathGDSF1265GDSF12652024-12-02
00733132658923GORE® DrySeal Flex Introducer SheathGDSF1433GDSF14332024-12-02
00733132658930GORE® DrySeal Flex Introducer SheathGDSF1465GDSF14652024-12-02
00733132658947GORE® DrySeal Flex Introducer SheathGDSF1533GDSF15332024-12-02
00733132658954GORE® DrySeal Flex Introducer SheathGDSF1633GDSF16332024-12-02
00733132658961GORE® DrySeal Flex Introducer SheathGDSF1665GDSF16652024-12-02
00733132658978GORE® DrySeal Flex Introducer SheathGDSF1833GDSF18332024-12-02
00733132658985GORE® DrySeal Flex Introducer SheathGDSF1865GDSF18652024-12-02
00733132658992GORE® DrySeal Flex Introducer SheathGDSF2033GDSF20332024-12-02
00733132659005GORE® DrySeal Flex Introducer SheathGDSF2065GDSF20652024-12-02
00733132659012GORE® DrySeal Flex Introducer SheathGDSF2233GDSF22332024-12-02
00733132659029GORE® DrySeal Flex Introducer SheathGDSF2265GDSF22652024-12-02
00733132659036GORE® DrySeal Flex Introducer SheathGDSF2433GDSF24332024-12-02
00733132659043GORE® DrySeal Flex Introducer SheathGDSF2465GDSF24652024-12-02

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00811806011295Amplatzer™ST. JUDE MEDICAL, INC.MLV2026-07-31
05415067033307Amplatzer™ Talisman™ST. JUDE MEDICAL, INC.MLV2021-09-29
05415067033314Amplatzer™ Talisman™ST. JUDE MEDICAL, INC.MLV2021-09-29
05415067033321Amplatzer™ Talisman™ST. JUDE MEDICAL, INC.MLV2021-09-29
05415067033345Amplatzer™ Talisman™ST. JUDE MEDICAL, INC.MLV2021-09-29
00733132636525GORE CARDIOFORM ASD OccluderW. L. Gore & Associates, Inc.MLV2019-08-07
00733132636488GORE CARDIOFORM ASD OccluderW. L. Gore & Associates, Inc.MLV2019-07-03
00733132636495GORE CARDIOFORM ASD OccluderW. L. Gore & Associates, Inc.MLV2019-07-03
00733132636501GORE CARDIOFORM ASD OccluderW. L. Gore & Associates, Inc.MLV2019-07-03
05415067028105Amplatzer™AGA MEDICAL CORPORATIONMLV2017-02-22
05415067028112Amplatzer™AGA MEDICAL CORPORATIONMLV2017-02-22
05415067028129Amplatzer™AGA MEDICAL CORPORATIONMLV2017-02-22
05415067028136Amplatzer™AGA MEDICAL CORPORATIONMLV2017-02-22
05415067028143Amplatzer™AGA MEDICAL CORPORATIONMLV2017-02-22
00733132606979GORE HELEX Septal OccluderW. L. Gore & Associates, Inc.MLV2017-02-13
00733132606986GORE HELEX Septal OccluderW. L. Gore & Associates, Inc.MLV2017-02-13
00733132606993GORE HELEX Septal OccluderW. L. Gore & Associates, Inc.MLV2017-02-13
00733132607006GORE HELEX Septal OccluderW. L. Gore & Associates, Inc.MLV2017-02-13
00733132607013GORE HELEX Septal OccluderW. L. Gore & Associates, Inc.MLV2017-02-13
H373HX201533GORE HELEX Septal OccluderW. L. Gore & Associates, Inc.MLV2017-02-13
H373HX20203GORE HELEX Septal OccluderW. L. Gore & Associates, Inc.MLV2017-02-13
H373HX202534GORE HELEX Septal OccluderW. L. Gore & Associates, Inc.MLV2017-02-13
H373HX203030GORE HELEX Septal OccluderW. L. Gore & Associates, Inc.MLV2017-02-13
H373HX203535GORE HELEX Septal OccluderW. L. Gore & Associates, Inc.MLV2017-02-13
00733132617609Gore Septal OccluderW. L. Gore & Associates, Inc.MLV2017-02-13
00733132631001GORE CARDIOFORM Septal OccluderW. L. Gore & Associates, Inc.MLV2017-02-13
00733132631018GORE CARDIOFORM Septal OccluderW. L. Gore & Associates, Inc.MLV2017-02-13
00733132631025GORE CARDIOFORM Septal OccluderW. L. Gore & Associates, Inc.MLV2017-02-13
00733132631032GORE CARDIOFORM Septal OccluderW. L. Gore & Associates, Inc.MLV2017-02-13
00811806011271Amplatzer™ST. JUDE MEDICAL, INC.MLV2016-11-08