FDA.reportPublic FDA data

GORE HELEX Septal Occluder

Primary DI
H373HX202534
Brand
GORE HELEX Septal Occluder
Company
W. L. Gore & Associates, Inc.
Model
HX2025
Published
2017-02-13
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
MR Conditional
Rx
true
OTC
false
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
P050006037

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P050006037GORE HELEX SEPTAL OCCLUDERW. L. Gore & Associates, Inc.2006-08-11MLV

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00733132606993PrimaryGS10
H373HX202534SecondaryHIBCC0

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00733132606993007331326069937331326069930733132606993

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
Length75Centimeter
Outer Diameter25Millimeter

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
8005288763mpdcustomercare@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
false
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
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
00733132636518GORE 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
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