Consulting Wallah › Device Explorer › Catheters & tubes › Cardiac mapping catheter, percutaneous, single-use
Device Explorer · FDA GUDID · GMDN 46355

Cardiac mapping catheter, percutaneous, single-use

A sterile, steerable, flexible tube containing multiple electrodes that is introduced percutaneously into the heart chambers in order to transmit electrical impulses for electrophysiological diagnostic examinations, e.g., intracardiac sensing, endocardial reco

US‑registered devices931in commercial distribution
Companies17labelers on GUDID
Single‑use99%of device records
Sterile100%labelled sterile
Prescription94%Rx‑only share
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Share of device records

Boston Scientific Corporation24326%
Biosense Webster Inc20722%
St. Jude Medical Cardiovascular Division13314%
Irvine Biomedical, Inc.12213%
Shanghai Microport Ep Medtech Co., Ltd.566%
Medtronic, Inc.485%
Access Point Technologies, Inc.414%
St. Jude Medical, Inc.283%

Top labelers

CompanyDevicesShare
Boston Scientific Corporation24326%
Biosense Webster Inc20722%
St. Jude Medical Cardiovascular Division13314%
Irvine Biomedical, Inc.12213%
Shanghai Microport Ep Medtech Co., Ltd.566%
Medtronic, Inc.485%
Access Point Technologies, Inc.414%
St. Jude Medical, Inc.283%
Vascomed Gmbh273%
Abbott71%
Synaptic Medical, Ltd.40%
Cortex, Inc.40%

Company = labeler of record on GUDID. 17 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

EasyFinder Fixed Curve Diagnostic CatheterEasyFinder Fixed Curve Diagnostic catheterN/ANAAdvisor™ HD Grid X, Sensor Enabled™Advisor™ HD Grid, Sensor Enabled™Advisor™ VL, Sensor Enabled™Advisor™Inquiry™Inquiry™ AFocus II™Reflexion HD™Livewire™Reflexion Spiral™SJM™EnSite™Supreme™

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

FDA product codes

CodeNameDevices
DRFCATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING896
DRFCatheter, Electrode Recording, Or Probe, Electrode Recording110
DRACATHETER, STEERABLE39
MTDCATHETER,INTRACARDIAC MAPPING,HIGH-DENSITY ARRAY25
MTDCatheter, intracardiac mapping, high-density array10
MTDCatheter, Intracardiac Mapping, High-Density Array6

GMDN & GCC registration

  • GMDN code 46355 · non‑implantable
  • Single‑use 99% · sterile 100% · Rx‑only 94% · 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

Catheter Gauge (French) · 319Length (Centimeter) · 83Circumference (Millimeter) · 3Length (Millimeter) · 1Outer Diameter (Millimeter) · 1

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

How many cardiac mapping catheter, percutaneous, single-use products are registered in the US?

931 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Cardiac mapping catheter, percutaneous, single-use", from 17 companies. The largest labeler is Boston Scientific Corporation with 26% of records.

Which FDA product codes apply?

DRF (CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING), DRF (Catheter, Electrode Recording, Or Probe, Electrode Recording), DRA (CATHETER, STEERABLE), MTD (CATHETER,INTRACARDIAC MAPPING,HIGH-DENSITY ARRAY)

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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