Consulting Wallah › Device Explorer › Cardiovascular › Bare-metal intracranial vascular stent
Device Explorer · FDA GUDID · GMDN 46352

Bare-metal intracranial vascular stent

A non-bioabsorbable tubular device typically intended to be implanted into the base or parent artery of an intracranial aneurysm (e.g., wide-neck aneurysm situated at the base of a bifurcation) to facilitate the delivery of embolics to fill the aneurysm, facil

US‑registered devices1,085in commercial distribution
Companies6labelers on GUDID
Single‑use100%of device records
Sterile100%labelled sterile
Prescription100%Rx‑only share
ImplantableYesGMDN flag
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Share of device records

Micro Therapeutics, Inc.72567%
Stryker Corporation20119%
Microvention, Inc.14613%
Medos International Sàrl81%
Rapid Medical Ltd40%
Covidien Lp10%

Top labelers

CompanyDevicesShare
Micro Therapeutics, Inc.72567%
Stryker Corporation20119%
Microvention, Inc.14613%
Medos International Sàrl81%
Rapid Medical Ltd40%
Covidien Lp10%

Company = labeler of record on GUDID. 6 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

Surpass EliteSurpass EvolveNeuroform AtlasSurpass StreamlineBraidE Embolization Assist DeviceComaneci 17Comaneci PetitComaneciWingspanNEUROFORM EZ 3PipelineTM Vantage Embolization Device with ShiePIPELINESolitaire 2StentLVISLVIS Jr.

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

FDA product codes

CodeNameDevices
OUTIntracranial aneurysm flow diverter965
NJEintracranial neurovascular stent127
QCAIntracranial coil-assist stent34
NJEIntracranial Neurovascular Stent20
QCAIntracranial Coil-Assist Stent20
PUUTemporary Coil Embolization Assist Device3

GMDN & GCC registration

  • GMDN code 46352 · 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 (Millimeter) · 599Outer Diameter (Millimeter) · 350Lumen/Inner Diameter (Millimeter) · 160

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

How many bare-metal intracranial vascular stent products are registered in the US?

1,085 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Bare-metal intracranial vascular stent", from 6 companies. The largest labeler is Micro Therapeutics, Inc. with 67% of records.

Which FDA product codes apply?

OUT (Intracranial aneurysm flow diverter), NJE (intracranial neurovascular stent), QCA (Intracranial coil-assist stent), NJE (Intracranial Neurovascular Stent)

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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