Consulting Wallah › Device Explorer › Catheters & tubes › Peripheral angioplasty balloon catheter, basic
Device Explorer · FDA GUDID · GMDN 17184

Peripheral angioplasty balloon catheter, basic

A sterile, non-drug-eluting, flexible tube designed for percutaneous transluminal angioplasty (PTA) to dilate a stenotic peripheral (i.e., non-cerebral, non-coronary) artery by controlled inflation of a distensible balloon(s) at its distal tip; it may also be

US‑registered devices18,924in commercial distribution
Companies41labelers on GUDID
Single‑use100%of device records
Sterile99%labelled sterile
Prescription64%Rx‑only share
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Share of device records

Brosmed Medical Co.,Ltd.4,37023%
Orbusneich Medical (Shenzhen) Co., Ltd.1,6729%
Bard Peripheral Vascular, Inc.1,4798%
Medtronic, Inc.1,3627%
Natec Medical Ltd1,2807%
Boston Scientific Corporation1,1586%
Kaneka Corporation8014%
Ev3, Inc7204%

Top labelers

CompanyDevicesShare
Brosmed Medical Co.,Ltd.4,37023%
Orbusneich Medical (Shenzhen) Co., Ltd.1,6729%
Bard Peripheral Vascular, Inc.1,4798%
Medtronic, Inc.1,3627%
Natec Medical Ltd1,2807%
Boston Scientific Corporation1,1586%
Kaneka Corporation8014%
Ev3, Inc7204%
Cordis Us Corp.7154%
Cook Incorporated6844%
Covidien Lp6133%
Cordis Corporation4843%

Company = labeler of record on GUDID. 41 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

ChameleonchameleonPROTEUSPTA Scoring Balloon Dilatation CatheterVelaNavajoTiche PTA Balloon Dilatation CatheterTri-Wedge PTA Scoring Balloon Dilatation CatheteHermes NC PTA Balloon Dilatation CatheterAtropos PTA Balloon Dilatation CatheterPolux PTA Balloon Dilatation CatheterPolux PTA Balloon Dilatation Catheterrev 01Castor NC PTA Balloon Dilatation CatheterAchilles NC PTA Balloon Dilatation CatheterMinerva PTA Balloon Dilatation CatheterFalexpand HP PTA Balloon Dilatation Catheter

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

FDA product codes

CodeNameDevices
LITCatheter, Angioplasty, Peripheral, Transluminal9,721
LITCatheter, angioplasty, peripheral, transluminal8,426
DQYCATHETER, PERCUTANEOUS2,788
DQYCatheter, percutaneous842
PNOCatheter, Percutaneous, Cutting/Scoring690
DQYCatheter, Percutaneous518

GMDN & GCC registration

  • GMDN code 17184 · non‑implantable
  • Single‑use 100% · sterile 99% · Rx‑only 64% · 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

Outer Diameter (Millimeter) · 3,449Length (Millimeter) · 3,265Balloon Length (Millimeter) · 2,172Balloon Diameter (Millimeter) · 2,147Catheter Gauge (French) · 1,002Catheter Working Length (Centimeter) · 734

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

How many peripheral angioplasty balloon catheter, basic products are registered in the US?

18,924 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Peripheral angioplasty balloon catheter, basic", from 41 companies. The largest labeler is Brosmed Medical Co.,Ltd. with 23% of records.

Which FDA product codes apply?

LIT (Catheter, Angioplasty, Peripheral, Transluminal), LIT (Catheter, angioplasty, peripheral, transluminal), 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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