Consulting Wallah › Device Explorer › Cardiovascular › Cardiac/peripheral vascular guidewire, single-use
Device Explorer · FDA GUDID · GMDN 35094

Cardiac/peripheral vascular guidewire, single-use

A long, thin, sterile wire intended to be percutaneously placed into the cardiac vasculature (ventricles or coronary vessels) to function as a guide for the introduction, positioning, and/or operation of a device (e.g., catheter, pacing lead); it may also be u

US‑registered devices2,176in commercial distribution
Companies64labelers on GUDID
Single‑use100%of device records
Sterile96%labelled sterile
Prescription83%Rx‑only share
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Share of device records

Medtronic, Inc.1919%
Shanghai Kindly Medical Instruments Co., Ltd.1758%
Merit Medical Systems, Inc.1738%
Asahi Intecc Co., Ltd.1668%
Terumo Corporation1648%
Abbott Vascular Inc.1597%
Boston Scientific Corporation1557%
Covidien Lp1055%

Top labelers

CompanyDevicesShare
Medtronic, Inc.1919%
Shanghai Kindly Medical Instruments Co., Ltd.1758%
Merit Medical Systems, Inc.1738%
Asahi Intecc Co., Ltd.1668%
Terumo Corporation1648%
Abbott Vascular Inc.1597%
Boston Scientific Corporation1557%
Covidien Lp1055%
Lepu Medical Technology (Beijing) Co.,Ltd.864%
Cordis Us Corp.834%
St. Jude Medical, Inc.653%
Cordis Corporation633%

Company = labeler of record on GUDID. 64 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

Synchro SELECTSynchro2SYNCHRO 10SYNCHRO 14 SSYNCHRO 14SavvyWireDrivewire 35 GuidewireDrivewire 24 GuidewireDrivewire SRDrivewire LRInno-pathwireInno-PathwireDCwire™INT, FirstWireINT,Denali Guide WireINT,FineThrough

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

FDA product codes

CodeNameDevices
DQXWIRE, GUIDE, CATHETER1,202
DQXWire, Guide, Catheter778
DQXWire, guide, catheter561
MOFGuide, Wire, Catheter, Neurovasculature90
GCJLaparoscope, general & plastic surgery71
MOFGUIDE, WIRE, CATHETER, NEUROVASCULATURE34

GMDN & GCC registration

  • GMDN code 35094 · non‑implantable
  • Single‑use 100% · sterile 96% · Rx‑only 83% · 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) · 1,031Outer Diameter (Inch) · 711Outer Diameter (Millimeter) · 368Guidewire Length (Centimeter) · 107Guidewire Diameter (Inch) · 97Length (Inch) · 4

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

How many cardiac/peripheral vascular guidewire, single-use products are registered in the US?

2,176 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Cardiac/peripheral vascular guidewire, single-use", from 64 companies. The largest labeler is Medtronic, Inc. with 9% of records.

Which FDA product codes apply?

DQX (WIRE, GUIDE, CATHETER), DQX (Wire, Guide, Catheter), DQX (Wire, guide, catheter), MOF (Guide, Wire, Catheter, Neurovasculature)

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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