Consulting Wallah › Device Explorer › Cardiovascular › Peripheral artery endovascular stent-graft, drug-c
Device Explorer · FDA GUDID · GMDN 66619

Peripheral artery endovascular stent-graft, drug-coated

A non-bioabsorbable tubular implantable device intended to maintain patency and improve luminal diameter of a peripheral artery (excludes aorta, coronary, pulmonary, and intracranial arteries), and that includes a heparin coating intended to prevent thrombotic

US‑registered devices223in commercial distribution
Companies1labelers on GUDID
Single‑use100%of device records
Sterile100%labelled sterile
Prescription93%Rx‑only share
ImplantableYesGMDN flag
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Share of device records

W. L. Gore & Associates, Inc.223100%

Top labelers

CompanyDevicesShare
W. L. Gore & Associates, Inc.223100%

Company = labeler of record on GUDID. 1 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

GOREGORE VIABAHN VBX Balloon Expandable EndoGORE VIABAHN Endoprosthesis with Heparin

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

FDA product codes

CodeNameDevices
NIPStent, Superficial Femoral Artery150
PFVSystem, Endovascular Graft, Arteriovenous (Av) Dialysis Acce150
PRLIliac covered stent, arterial76
PRLIliac Covered Stent, Arterial76

GMDN & GCC registration

  • GMDN code 66619 · implantable
  • Single‑use 100% · sterile 100% · Rx‑only 93% · 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) · 210Lumen/Inner Diameter (Millimeter) · 205Catheter Gauge (French) · 148Outer Diameter (Millimeter) · 81Length (Millimeter) · 76Catheter Working Length (Centimeter) · 11

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

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

223 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, drug-coated", from 1 companies. The largest labeler is W. L. Gore & Associates, Inc. with 100% of records.

Which FDA product codes apply?

NIP (Stent, Superficial Femoral Artery), PFV (System, Endovascular Graft, Arteriovenous (Av) Dialysis Acce), 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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