Consulting Wallah › Device Explorer › Catheters & tubes › Intravascular occluding balloon catheter, image-gu
Device Explorer · FDA GUDID · GMDN 32584

Intravascular occluding balloon catheter, image-guided

A non-powered flexible tube with an inflatable balloon(s) at the distal end intended to be introduced short-term under image guidance to temporarily block a blood vessel. It may be used for arteriography, selective angiography, preoperative occlusion, peripher

US‑registered devices344in commercial distribution
Companies33labelers on GUDID
Single‑use100%of device records
Sterile99%labelled sterile
Prescription93%Rx‑only share
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Share of device records

Numed, Inc.7121%
Thermopeutix, Inc.4212%
Micro Therapeutics, Inc.4012%
Microvention, Inc.309%
Lucas Medical Inc309%
Lemaitre Vascular, Inc.196%
Stryker Corporation185%
Asahi Intecc Co., Ltd.113%

Top labelers

CompanyDevicesShare
Numed, Inc.7121%
Thermopeutix, Inc.4212%
Micro Therapeutics, Inc.4012%
Microvention, Inc.309%
Lucas Medical Inc309%
Lemaitre Vascular, Inc.196%
Stryker Corporation185%
Asahi Intecc Co., Ltd.113%
Boston Scientific Corporation113%
Qxmedical82%
Cook Incorporated82%
Balt Usa Llc62%

Company = labeler of record on GUDID. 33 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

TRANSFORMParagon 8F Balloon Guide CatheteBranchor XBranchor 9Fr 100cmBranchor 9Fr 90cmCELLO II Balloon Guide Catheter, 8F 90cmCELLO™, Balloon Guide CatheterFOGARTYER-REBOA CatheterMarblehead MedicalWalrusTerumo Aortic BalloonVitaleQ50XResQQ50 Plus

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

FDA product codes

CodeNameDevices
MJNCatheter, Intravascular Occluding, Temporary170
MJNCatheter, intravascular occluding, temporary111
DQYCATHETER, PERCUTANEOUS52
DQYCatheter, Percutaneous39
QJPCatheter, Percutaneous, Neurovasculature24
DQYCatheter, percutaneous17

GMDN & GCC registration

  • GMDN code 32584 · non‑implantable
  • Single‑use 100% · sterile 99% · Rx‑only 93% · OTC 5%
  • 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) · 42Length (Millimeter) · 34Outer Diameter (Millimeter) · 25Catheter Gauge (French) · 20Balloon Diameter (Millimeter) · 9Introducer Sheath Compatibility (French) · 8

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

How many intravascular occluding balloon catheter, image-guided products are registered in the US?

344 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Intravascular occluding balloon catheter, image-guided", from 33 companies. The largest labeler is Numed, Inc. with 21% of records.

Which FDA product codes apply?

MJN (Catheter, Intravascular Occluding, Temporary), MJN (Catheter, intravascular occluding, temporary), DQY (CATHETER, PERCUTANEOUS), DQY (Catheter, Percutaneous)

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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