FDA.reportPublic FDA data

Aorfix AAA Stent Graft Body with Aorflex Delivery System

Primary DI
05055715606806
Brand
Aorfix AAA Stent Graft Body with Aorflex Delivery System
Company
LOMBARD MEDICAL LIMITED
Model
SG-HBB-24-81-63-14-A12-22
Device description
Aorflex AAA Stent Graft Body with Aorflex Delivery System
Published
2015-04-29
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
MIHSystem, Endovascular Graft, Aortic Aneurysm Treatment

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MIHSystem, Endovascular Graft, Aortic Aneurysm TreatmentUnknown3

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
P110032000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P110032000AORFIX FLEXIBLE STENT GRAFT SYSTEMLombard Medical Limited2013-02-14MIH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05055715606806PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05055715606806050557156068065055715606806

GMDN Terms#

Term, Definition table
TermDefinition
Abdominal aorta endovascular stent-graftA sterile non-bioabsorbable tubular device typically implanted at the junction of the abdominal aorta and the common iliac arteries to reduce pressure on an abdominal aortic aneurysm (AAA). It is percutaneously inserted via the femoral artery to the site of implantation, with a disposable delivery device, where it self-expands. It is typically made of nickel-titanium alloy (Nitinol) that forms an outer mesh structure with an inner polymer tube (endovascular graft). It is typically available in two designs: 1) a single continuous tube for insertion into one iliac artery; or 2) a two-part bifurcation design (e.g., shaped as a Y in a tube form) for insertion through both iliac arteries.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+441235750800kirsty.cook@lombardmedical.com

Regulatory Flags#

DUNS number
775481088
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05055715606424Aorfix AAA Stent Graft Body with Aorflex Delivery SystemSG-HBB-24-111-63-10-A12-222015-04-28
05055715606431Aorfix AAA Stent Graft Body with Aorflex Delivery SystemSG-HBB-24-111-63-12-A12-222015-04-29
05055715606448Aorfix AAA Stent Graft Body with Aorflex Delivery SystemSG-HBB-24-111-63-14-A12-222015-04-29
05055715606455Aorfix AAA Stent Graft Body with Aorflex Delivery SystemSG-HBB-24-111-63-16-A12-222015-04-29
05055715606462Aorfix AAA Stent Graft Body with Aorflex Delivery SystemSG-HBB-24-111-63-18-A12-222015-04-29
05055715606479Aorfix AAA Stent Graft Body with Aorflex Delivery SystemSG-HBB-24-111-63-20-A12-222015-04-29
05055715606486Aorfix AAA Stent Graft Body with Aorflex Delivery SystemSG-HBB-24-111-80-10-A12-222015-04-29
05055715606493Aorfix AAA Stent Graft Body with Aorflex Delivery SystemSG-HBB-24-111-80-12-A12-222015-04-29
05055715606509Aorfix AAA Stent Graft Body with Aorflex Delivery SystemSG-HBB-24-111-80-14-A12-222015-04-29
05055715606516Aorfix AAA Stent Graft Body with Aorflex Delivery SystemSG-HBB-24-111-80-16-A12-222015-04-29
05055715606523Aorfix AAA Stent Graft Body with Aorflex Delivery SystemSG-HBB-24-111-80-18-A12-222015-04-29
05055715606530Aorfix AAA Stent Graft Body with Aorflex Delivery SystemSG-HBB-24-111-80-20-A12-222015-04-29
05055715606547Aorfix AAA Stent Graft Body with Aorflex Delivery SystemSG-HBB-24-111-97-10-A12-222015-04-29
05055715606554Aorfix AAA Stent Graft Body with Aorflex Delivery SystemSG-HBB-24-111-97-12-A12-222015-04-29
05055715606561Aorfix AAA Stent Graft Body with Aorflex Delivery SystemSG-HBB-24-111-97-14-A12-222015-04-29
05055715606578Aorfix AAA Stent Graft Body with Aorflex Delivery SystemSG-HBB-24-111-97-16-A12-222015-04-29
05055715606585Aorfix AAA Stent Graft Body with Aorflex Delivery SystemSG-HBB-24-111-97-18-A12-222015-04-29
05055715606592Aorfix AAA Stent Graft Body with Aorflex Delivery SystemSG-HBB-24-111-97-20-A12-222015-04-29
05055715606608Aorfix AAA Stent Graft Body with Aorflex Delivery SystemSG-HBB-24-126-63-10-A12-222015-04-29
05055715606615Aorfix AAA Stent Graft Body with Aorflex Delivery SystemSG-HBB-24-126-63-12-A12-222015-04-29

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00827002599819Zenith AlphaWilliam Cook Europe ApSMIH2024-12-04
00827002599840Zenith AlphaWilliam Cook Europe ApSMIH2024-12-04
00827002599871Zenith AlphaWilliam Cook Europe ApSMIH2024-12-04
00827002599901Zenith AlphaWilliam Cook Europe ApSMIH2024-12-04
00827002599932Zenith AlphaWilliam Cook Europe ApSMIH2024-12-04
00827002599963Zenith AlphaWilliam Cook Europe ApSMIH2024-12-04
00827002599994Zenith AlphaWilliam Cook Europe ApSMIH2024-12-04
00827002600027Zenith AlphaWilliam Cook Europe ApSMIH2024-12-04
00827002600058Zenith AlphaWilliam Cook Europe ApSMIH2024-12-04
00827002600089Zenith AlphaWilliam Cook Europe ApSMIH2024-12-04
00827002600119Zenith AlphaWilliam Cook Europe ApSMIH2024-12-04
00827002600140Zenith AlphaWilliam Cook Europe ApSMIH2024-12-04
00827002600171Zenith AlphaWilliam Cook Europe ApSMIH2024-12-04
00827002600201Zenith AlphaWilliam Cook Europe ApSMIH2024-12-04
00827002600232Zenith AlphaWilliam Cook Europe ApSMIH2024-12-04
00827002600263Zenith AlphaWilliam Cook Europe ApSMIH2024-12-04
00827002600294Zenith AlphaWilliam Cook Europe ApSMIH2024-12-04
00827002600324Zenith AlphaWilliam Cook Europe ApSMIH2024-12-04
00827002600355Zenith AlphaWilliam Cook Europe ApSMIH2024-12-04
00827002600393Zenith AlphaWilliam Cook Europe ApSMIH2024-12-04
00827002600409Zenith AlphaWilliam Cook Europe ApSMIH2024-12-04
00827002600430Zenith AlphaWilliam Cook Europe ApSMIH2024-12-04
00827002600461Zenith AlphaWilliam Cook Europe ApSMIH2024-12-04
00827002600492Zenith AlphaWilliam Cook Europe ApSMIH2024-12-04
00827002600522Zenith AlphaWilliam Cook Europe ApSMIH2024-12-04
00827002600553Zenith AlphaWilliam Cook Europe ApSMIH2024-12-04
00827002600584Zenith AlphaWilliam Cook Europe ApSMIH2024-12-04
00827002600614Zenith AlphaWilliam Cook Europe ApSMIH2024-12-04
00827002600645Zenith AlphaWilliam Cook Europe ApSMIH2024-12-04
00827002600676Zenith AlphaWilliam Cook Europe ApSMIH2024-12-04