Consulting Wallah › Device Explorer › Catheters & tubes › Thrombectomy balloon catheter
Device Explorer · FDA GUDID · GMDN 58174

Thrombectomy balloon catheter

A flexible tube designed for the percutaneous, transluminal disruption and removal of clotted blood (i.e., a thrombus or thromboembolus) causing vascular obstruction in native and stented blood vessels, native and synthetic bypass grafts, and/or haemodialysis

US‑registered devices355in commercial distribution
Companies7labelers on GUDID
Single‑use100%of device records
Sterile100%labelled sterile
Prescription100%Rx‑only share
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Share of device records

Lucas Medical Inc10329%
Lemaitre Vascular, Inc.9627%
Applied Medical Resources Corporation6619%
Edwards Lifesciences Llc5014%
Becton, Dickinson And Company278%
Bioptimal International Pte. Ltd.123%
Ichor Vascular, Inc.10%

Top labelers

CompanyDevicesShare
Lucas Medical Inc10329%
Lemaitre Vascular, Inc.9627%
Applied Medical Resources Corporation6619%
Edwards Lifesciences Llc5014%
Becton, Dickinson And Company278%
Bioptimal International Pte. Ltd.123%
Ichor Vascular, Inc.10%

Company = labeler of record on GUDID. 7 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

FOGARTY FORTISFogartyFOGARTYFogarty CorkscrewICHORLMI ARTERIAL EMBOLECTOMY CATHETER (BD)LMI ARTERIAL EMBOLECTOMY CATHETER (EDW)Latis Silicone Graft Cleaning CatheterSyntel Silicone OTW Embolectomy CatheterSyntel Silicone Thrombectomy CatheterSyntel Silicone Embolectomy CatheterLeMaitre Embolectomy CatheterFOGARTY CORKSCREWBard Latex Free Thrombectomy CatheterBARD Latex-free Arterial Embolectomy CathetersBARD

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

FDA product codes

CodeNameDevices
DXECatheter, Embolectomy298
DXECATHETER, EMBOLECTOMY38
DXECatheter, embolectomy25
KRACatheter, continuous flush10
KRACatheter, Continuous Flush10
MCWCatheter, peripheral, atherectomy4

GMDN & GCC registration

  • GMDN code 58174 · non‑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) · 92Catheter Gauge (French) · 56Total Volume (Milliliter) · 17Catheter Working Length (Centimeter) · 12Catheter Length (Centimeter) · 10Total Volume (Microliter) · 1

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

How many thrombectomy balloon catheter products are registered in the US?

355 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Thrombectomy balloon catheter", from 7 companies. The largest labeler is Lucas Medical Inc with 29% of records.

Which FDA product codes apply?

DXE (Catheter, Embolectomy), DXE (CATHETER, EMBOLECTOMY), DXE (Catheter, embolectomy), KRA (Catheter, continuous flush)

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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