FDA.reportPublic FDA data

NEXUS Aortic Arch Stent Graft System

Primary DI
07290116280134
Brand
NEXUS Aortic Arch Stent Graft System
Company
ENDOSPAN LTD
Model
M-A-ES-1020
Published
2026-05-10
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
SDZEndovascular System For Treatment Of Ascending Aorta And Aortic Arch Lesions

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
SDZEndovascular System For Treatment Of Ascending Aorta And Aortic Arch LesionsUnknown3

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
P250033000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P250033000NEXUS Aortic Arch Stent Graft SystemEndospan , Ltd.2026-04-02SDZ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07290116280134PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07290116280134072901162801347290116280134

GMDN Terms#

Term, Definition table
TermDefinition
Aortic arch endovascular stent-graftA non-bioabsorbable tubular device intended for endovascular implantation, in a modular configuration, to repair lesions of the aortic arch and descending thoracic aorta. It is typically made of a metal alloy [e.g., nickel-titanium alloy (Nitinol)] that forms an outer mesh structure with an inner synthetic polymer tube (endovascular graft). It includes a docking portal(s) for attachment of an ancillary endovascular stent-graft(s) [not included] to occupy and allow flow to an aortic arch branch vessel(s). It is percutaneously inserted via the femoral artery to the site of implantation and expanded in situ; disposable devices associated with implantation may be included.

Regulatory Flags#

DUNS number
532700825
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
07290116280004NEXUS Aortic Arch Stent Graft SystemM-A-ES-1020 2026-05-10
07290116280011NEXUS Aortic Arch Stent Graft SystemM-A-ES-1020 2026-05-10
07290116280028NEXUS Aortic Arch Stent Graft SystemM-A-ES-1020 2026-05-10
07290116280035NEXUS Aortic Arch Stent Graft SystemM-A-ES-1020 2026-05-10
07290116280042NEXUS Aortic Arch Stent Graft SystemM-A-ES-1020 2026-05-10
07290116280059NEXUS Aortic Arch Stent Graft SystemM-A-ES-1020 2026-05-10
07290116280066NEXUS Aortic Arch Stent Graft SystemM-A-ES-1020 2026-05-10
07290116280073NEXUS Aortic Arch Stent Graft SystemM-A-ES-1020 2026-05-10
07290116280080NEXUS Aortic Arch Stent Graft SystemM-A-ES-1020 2026-05-10
07290116280097NEXUS Aortic Arch Stent Graft SystemM-A-ES-1020 2026-05-10
07290116280103NEXUS Aortic Arch Stent Graft SystemM-A-ES-1020 2026-05-10
07290116280110NEXUS Aortic Arch Stent Graft SystemM-A-ES-1020 2026-05-10
07290116280127NEXUS Aortic Arch Stent Graft SystemM-A-ES-1020 2026-05-10
07290116280141NEXUS Aortic Arch Stent Graft SystemM-A-ES-1020 2026-05-10
07290116280158NEXUS Aortic Arch Stent Graft SystemM-A-ES-1020 2026-05-10
07290116280165NEXUS Aortic Arch Stent Graft SystemM-A-ES-1020 2026-05-10
07290116280172NEXUS Aortic Arch Stent Graft SystemM-A-ES-1020 2026-05-10
07290116280189NEXUS Aortic Arch Stent Graft SystemM-A-ES-1020 2026-05-10
07290116280196NEXUS Aortic Arch Stent Graft SystemM-A-ES-1020 2026-05-10
07290116280202NEXUS Aortic Arch Stent Graft SystemM-A-ES-1020 2026-05-10

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07290116280004NEXUS Aortic Arch Stent Graft SystemENDOSPAN LTDSDZ2026-05-10
07290116280011NEXUS Aortic Arch Stent Graft SystemENDOSPAN LTDSDZ2026-05-10
07290116280028NEXUS Aortic Arch Stent Graft SystemENDOSPAN LTDSDZ2026-05-10
07290116280035NEXUS Aortic Arch Stent Graft SystemENDOSPAN LTDSDZ2026-05-10
07290116280042NEXUS Aortic Arch Stent Graft SystemENDOSPAN LTDSDZ2026-05-10
07290116280059NEXUS Aortic Arch Stent Graft SystemENDOSPAN LTDSDZ2026-05-10
07290116280066NEXUS Aortic Arch Stent Graft SystemENDOSPAN LTDSDZ2026-05-10
07290116280073NEXUS Aortic Arch Stent Graft SystemENDOSPAN LTDSDZ2026-05-10
07290116280080NEXUS Aortic Arch Stent Graft SystemENDOSPAN LTDSDZ2026-05-10
07290116280097NEXUS Aortic Arch Stent Graft SystemENDOSPAN LTDSDZ2026-05-10
07290116280103NEXUS Aortic Arch Stent Graft SystemENDOSPAN LTDSDZ2026-05-10
07290116280110NEXUS Aortic Arch Stent Graft SystemENDOSPAN LTDSDZ2026-05-10
07290116280127NEXUS Aortic Arch Stent Graft SystemENDOSPAN LTDSDZ2026-05-10
07290116280141NEXUS Aortic Arch Stent Graft SystemENDOSPAN LTDSDZ2026-05-10
07290116280158NEXUS Aortic Arch Stent Graft SystemENDOSPAN LTDSDZ2026-05-10
07290116280165NEXUS Aortic Arch Stent Graft SystemENDOSPAN LTDSDZ2026-05-10
07290116280172NEXUS Aortic Arch Stent Graft SystemENDOSPAN LTDSDZ2026-05-10
07290116280189NEXUS Aortic Arch Stent Graft SystemENDOSPAN LTDSDZ2026-05-10
07290116280196NEXUS Aortic Arch Stent Graft SystemENDOSPAN LTDSDZ2026-05-10
07290116280202NEXUS Aortic Arch Stent Graft SystemENDOSPAN LTDSDZ2026-05-10
07290116280219NEXUS Aortic Arch Stent Graft SystemENDOSPAN LTDSDZ2026-05-10
07290116280226NEXUS Aortic Arch Stent Graft SystemENDOSPAN LTDSDZ2026-05-10
07290116280233NEXUS Aortic Arch Stent Graft SystemENDOSPAN LTDSDZ2026-05-10
07290116280240NEXUS Aortic Arch Stent Graft SystemENDOSPAN LTDSDZ2026-05-10
07290116280257NEXUS Aortic Arch Stent Graft SystemENDOSPAN LTDSDZ2026-05-10
07290116280264NEXUS Aortic Arch Stent Graft SystemENDOSPAN LTDSDZ2026-05-10
07290116280271NEXUS Aortic Arch Stent Graft SystemENDOSPAN LTDSDZ2026-05-10
07290116280288NEXUS Aortic Arch Stent Graft SystemENDOSPAN LTDSDZ2026-05-10
07290116280295NEXUS Aortic Arch Stent Graft SystemENDOSPAN LTDSDZ2026-05-10
07290116280301NEXUS Aortic Arch Stent Graft SystemENDOSPAN LTDSDZ2026-05-10