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Device Explorer · FDA GUDID · GMDN 48060

Descending thoracic aorta/aortic isthmus endovascular stent-graft

A non-bioabsorbable tubular device intended to be percutaneously introduced for endovascular implantation primarily within the descending thoracic aorta and/or aortic isthmus to repair a lesion [e.g., thoracic aortic aneurysm (TAA), traumatic transections, dis

US‑registered devices2,982in commercial distribution
Companies5labelers on GUDID
Single‑use100%of device records
Sterile100%labelled sterile
Prescription100%Rx‑only share
ImplantableYesGMDN flag
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Share of device records

Bolton Medical Inc.2,47083%
William Cook Europe Aps2448%
B Braun Interventional Systems, Inc1164%
Medtronic, Inc.1054%
W. L. Gore & Associates, Inc.472%

Top labelers

CompanyDevicesShare
Bolton Medical Inc.2,47083%
William Cook Europe Aps2448%
B Braun Interventional Systems, Inc1164%
Medtronic, Inc.1054%
W. L. Gore & Associates, Inc.472%

Company = labeler of record on GUDID. 5 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

CP Stent™NuDELRelayPro Thoracic Stent-Graft SystemRelayPro NBS Thoracic Stent-Graft SystemRelay Plus Thoracic Stent-Graft SystemZenith AlphaGORE TAG Conformable Thoracic Stent GraftGORE® EXCLUDER® Thoracoabdominal Branch EndoprosGORE TAG Conformable Thoracic EndoprosthesisVALIANT® CaptiviaCOOK

Sample of brand names as labelled; no endorsement. Ask us for the full list with company, model and UDI.

FDA product codes

CodeNameDevices
MIHSystem, Endovascular Graft, Aortic Aneurysm Treatment2,696
MIHSYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT595
PNFAortic stent116
QZKEndovascular System For Treatment Of Thoracoabdominal And Pa2

GMDN & GCC registration

  • GMDN code 48060 · implantable
  • Single‑use 100% · sterile 100% · Rx‑only 100% · OTC 0%
  • UAE: MOHAP / DoH medical device registration and an authorised representative are required; Saudi: SFDA MDMA. We check status on request.

Size attributes recorded

Outer Diameter (Millimeter) · 4,954Catheter Gauge (French) · 2,650Length (Millimeter) · 2,633Length (Centimeter) · 63Lumen/Inner Diameter (Millimeter) · 12Balloon Catheter Tip Length (Millimeter) · 1

Use these as the dimensions to specify in a tender line.

How many descending thoracic aorta/aortic isthmus endovascular stent-graft products are registered in the US?

2,982 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Descending thoracic aorta/aortic isthmus endovascular stent-graft", from 5 companies. The largest labeler is Bolton Medical Inc. with 83% of records.

Which FDA product codes apply?

MIH (System, Endovascular Graft, Aortic Aneurysm Treatment), MIH (SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT), PNF (Aortic stent), QZK (Endovascular System For Treatment Of Thoracoabdominal And Pa)

Is this the same as UAE/GCC registration?

No. GUDID is the US register. For the UAE (MOHAP/DoH) and Saudi (SFDA/MDMA) a separate registration and a local authorised representative are required; Consulting Wallah can check the status and connect you with registered suppliers.

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Source: FDA AccessGUDID (AccessGUDID full release 2 Nov 2026); counts are device records in commercial distribution grouped by GMDN preferred term; companies are labelers of record. Information only — US listing is not a registration in the UAE or GCC; verify with the regulator. © Consulting Wallah — CC BY‑NC‑ND.

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