Consulting Wallah › Device Explorer › Catheters & tubes › Coronary angioplasty balloon catheter, basic
Device Explorer · FDA GUDID · GMDN 47732

Coronary angioplasty balloon catheter, basic

A flexible tube designed for percutaneous transluminal coronary angioplasty (PTCA) to dilate a stenotic coronary artery by controlled inflation of a distensible balloon(s) at its distal tip. It is typically available as: 1) an over-the-wire (OTW) type that has

US‑registered devices3,293in commercial distribution
Companies23labelers on GUDID
Single‑use100%of device records
Sterile98%labelled sterile
Prescription75%Rx‑only share
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Share of device records

Boston Scientific Corporation61819%
Medtronic, Inc.52216%
Abbott Vascular Inc.33510%
Orbusneich Medical (Shenzhen) Co., Ltd.3029%
Brosmed Medical Co.,Ltd.2638%
Kaneka Corporation1926%
Dongguan Tt Medical, Inc.1575%
Meril Life Sciences Private Limited1495%

Top labelers

CompanyDevicesShare
Boston Scientific Corporation61819%
Medtronic, Inc.52216%
Abbott Vascular Inc.33510%
Orbusneich Medical (Shenzhen) Co., Ltd.3029%
Brosmed Medical Co.,Ltd.2638%
Kaneka Corporation1926%
Dongguan Tt Medical, Inc.1575%
Meril Life Sciences Private Limited1495%
Tactx Medical, Inc.1334%
Natec Medical Ltd1314%
Sino Medical Sciences Technology Inc.913%
Biotronik Ag883%

Company = labeler of record on GUDID. 23 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

Gallant™ PTCA Dilatation CatheterNC Gallant™ PTCA CatheterSelebrek PTCA Balloon Dilatation CatheterArtime Balloon Dilatation CatheterApollo Balloon Dilatation CatheterPOT PTCA Balloon Dilatation CatheterCatheters, transluminal coronary angioplasty,perArtimes Balloon Dilatation CatheterSC HONKYTONKNC ROCKSTARFirefighter NC ProSapphire NC ULTRA Coronary Dilatation CatheterSapphire ULTRA Coronary Dilatation CatheterSapphire II PRO Balloon Dilatation CatheterSapphire II ProSapphire NC Plus

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

FDA product codes

CodeNameDevices
LOXCatheters, transluminal coronary angioplasty, percutaneous1,727
LOXCatheters, Transluminal Coronary Angioplasty, Percutaneous1,668
MAFSTENT, CORONARY102
NIQCoronary drug-eluting stent92
NWXCatheter, Percutaneous Transluminal Coronary Angioplasty (Pt48
LITCatheter, Angioplasty, Peripheral, Transluminal46

GMDN & GCC registration

  • GMDN code 47732 · non‑implantable
  • Single‑use 100% · sterile 98% · Rx‑only 75% · 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) · 918Length (Millimeter) · 917Balloon Diameter (Millimeter) · 282Balloon Length (Millimeter) · 282Catheter Length (Centimeter) · 5Height (Millimeter) · 1

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

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

3,293 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Coronary angioplasty balloon catheter, basic", from 23 companies. The largest labeler is Boston Scientific Corporation with 19% of records.

Which FDA product codes apply?

LOX (Catheters, transluminal coronary angioplasty, percutaneous), LOX (Catheters, Transluminal Coronary Angioplasty, Percutaneous), MAF (STENT, CORONARY), NIQ (Coronary drug-eluting 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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