Consulting Wallah › Device Explorer › Cardiovascular › Synthetic vascular graft, non-medicated
Device Explorer · FDA GUDID · GMDN 35281

Synthetic vascular graft, non-medicated

An implantable artificial substitute for a blood vessel intended to replace, bypass or shunt a portion of peripheral vasculature (excludes coronary and cerebral arteries) due to a disease, injury, or for haemodialysis access. It is made of synthetic polymer ma

US‑registered devices2,824in commercial distribution
Companies12labelers on GUDID
Single‑use100%of device records
Sterile100%labelled sterile
Prescription100%Rx‑only share
ImplantableYesGMDN flag
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Share of device records

Vascutek Ltd1,71861%
Intervascular Sas33712%
W. L. Gore & Associates, Inc.1696%
Bard Peripheral Vascular, Inc.1535%
Maquet Cardiovascular Llc1415%
William A. Cook Australia Pty. Ltd.1014%
Atrium Medical Corporation823%
Cook Incorporated612%

Top labelers

CompanyDevicesShare
Vascutek Ltd1,71861%
Intervascular Sas33712%
W. L. Gore & Associates, Inc.1696%
Bard Peripheral Vascular, Inc.1535%
Maquet Cardiovascular Llc1415%
William A. Cook Australia Pty. Ltd.1014%
Atrium Medical Corporation823%
Cook Incorporated612%
Peca Labs, Inc.462%
Vascular Flow Technologies Ltd90%
Medtronic, Inc.60%
Phraxis Inc.10%

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

Brand names on the register (sample)

Spiral Flow Peripheral Vascular GraftSpiral Flow Vascular Arteriovenous GraftGelweave™Gelsoft Plus™Gelsoft™Gelweave Vascular ProsthesesThoraflex™ HybridGelsoft Plus Vascular ProsthesesVascutek Gelweave™ Vascular GraftsGelseal™EndoForceCOOKexGraftexGraft CarbonIMPRA® ePTFE Vascular GraftsVenaflo® ePTFE Vascular Grafts

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

FDA product codes

CodeNameDevices
DSYPROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER3,041
DSYProsthesis, Vascular Graft, Of 6mm And Greater Diameter480
DYFPROSTHESIS, VASCULAR GRAFT, OF LESS THEN 6MM DIAMETER407
MALGraft, Vascular, Synthetic/Biologic Composite278
MIHSYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT246
QSKHybrid stent graft, thoracic aortic lesion treatment120

GMDN & GCC registration

  • GMDN code 35281 · 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) · 2,760Lumen/Inner Diameter (Millimeter) · 2,560Stent Length (Millimeter) · 92Stent Diameter (Millimeter) · 91Length (Millimeter) · 42Height (Centimeter) · 5

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

How many synthetic vascular graft, non-medicated products are registered in the US?

2,824 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Synthetic vascular graft, non-medicated", from 12 companies. The largest labeler is Vascutek Ltd with 61% of records.

Which FDA product codes apply?

DSY (PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER), DSY (Prosthesis, Vascular Graft, Of 6mm And Greater Diameter), DYF (PROSTHESIS, VASCULAR GRAFT, OF LESS THEN 6MM DIAMETER), MAL (Graft, Vascular, Synthetic/Biologic Composite)

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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