Consulting Wallah › Device Explorer › Cardiovascular › Peripheral artery endovascular stent-graft, non-me
Device Explorer · FDA GUDID · GMDN 43526

Peripheral artery endovascular stent-graft, non-medicated

A non-bioabsorbable tubular device intended to be implanted in a peripheral artery (excludes aorta, coronary, pulmonary, and intracranial arteries) to maintain patency and improve luminal diameter, typically in patients with symptomatic peripheral vascular dis

US‑registered devices130in commercial distribution
Companies4labelers on GUDID
Single‑use100%of device records
Sterile100%labelled sterile
Prescription100%Rx‑only share
ImplantableYesGMDN flag
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Share of device records

Atrium Medical Corporation5240%
Clearstream Technologies Limited4232%
W. L. Gore & Associates, Inc.3527%
Bard Peripheral Vascular, Inc.11%

Top labelers

CompanyDevicesShare
Atrium Medical Corporation5240%
Clearstream Technologies Limited4232%
W. L. Gore & Associates, Inc.3527%
Bard Peripheral Vascular, Inc.11%

Company = labeler of record on GUDID. 4 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

LifeStreamFluency® Endovascular Stent GraftGORE VIABAHN EndoprosthesisiCast covered stent system, 10mm x 59mm x 120cmiCast Covered Stent System, 9mmX59mmX80cmiCast Covered Stent System, 9mmX38mmX80cmiCast covered stent system, 9mm x 32mm x 80cmiCast Covered Stent System, 8mmX59mmX80cmiCast Covered Stent System, 8mmX38mmX80cmiCast covered stent system, 8mm x 32mm x 80cmiCast Covered Stent System, 7mmX59mmX80cmiCast Covered Stent System, 7mmX38mmX80cmiCast covered stent system, 7mm x 32mm x 80cmiCast Covered Stent System, 7mmX22mmX80cmiCast Covered Stent System, 7mmX16mmX80cmiCast Covered Stent System, 6mmX59mmX80cm

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

FDA product codes

CodeNameDevices
PFVSystem, Endovascular Graft, Arteriovenous (Av) Dialysis Acce84
NIPStent, Superficial Femoral Artery84
PRLIliac Covered Stent, Arterial52
PRLIliac covered stent, arterial42
PFVSystem, endovascular graft, arteriovenous (AV) dialysis acce31

GMDN & GCC registration

  • GMDN code 43526 · 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

Length (Centimeter) · 84Lumen/Inner Diameter (Millimeter) · 74Stent Diameter (Millimeter) · 53Catheter Length (Centimeter) · 52Stent Length (Millimeter) · 50Catheter Gauge (French) · 16

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

How many peripheral artery endovascular stent-graft, non-medicated products are registered in the US?

130 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Peripheral artery endovascular stent-graft, non-medicated", from 4 companies. The largest labeler is Atrium Medical Corporation with 40% of records.

Which FDA product codes apply?

PFV (System, Endovascular Graft, Arteriovenous (Av) Dialysis Acce), NIP (Stent, Superficial Femoral Artery), PRL (Iliac Covered Stent, Arterial), PRL (Iliac covered stent, arterial)

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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