Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3017401510

FEI Number

3017401510

Entity Name

CATHVISION APS

City/State/Country

Copenhagen NV Hovedstaden, DK

Establishment Address

Lygten 37 st. th., Copenhagen NV Hovedstaden 2400, DK

Establishment Type(s)

Manufacture Medical Device,Complaint File Establishment per 21 CFR 820.198

Owner / Operator

CathVision ApS (Owner Number: 10085183)

Owner / Operator Contact Address

Lygten 37 st. th., Copenhagen NV, DK-NOTA 2400, DK

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K223787

PMA Number

N/A

All Registered Proprietary Names

ECGenius System

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
DQK	Computer, Diagnostic, Programmable	Cardiovascular	Class 2	870.1425	2023-08-15

Official Correspondent

Mads Matthiesen

US Agent Details

Melissa Walker Business: Graematter, Inc Email: mwalker@graematter.com Phone: (636) 4057498

Related Public Records

Same Entity

CathVision ApS

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K935043	Siemens Medical Electronics	SIEMENS CLINICAL WORK STATION	1995-04-07
K170948	Acutus Medical, Inc.	AcQMap High Resolution Imaging and Mapping System	2017-10-16
K242016	ABBOTT MEDICAL	EnSite X EP System	2024-08-09
K172182	St. Jude Medical (Now Part of the Abbott Medical)	QUANTIEN Measurement System	2017-08-18
K252013	ABBOTT MEDICAL	EnSite X EP System	2025-09-25

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0002-2016	Biosense Webster, Inc.	2	Carto 3 EP Navigation System. Electro physiology system which views of the electrical activity of the heart through real-time data on 3-D, color-coded cardiac maps.
Z-0032-05	Siemens Medical Solutions USA, Inc	2	AXIOM Sensis Programmable diagnostic computer, Model number 66 23 974.
Z-0033-05	Siemens Medical Solutions USA, Inc	2	AXIOM Sensis Programmable diagnostic computer, Model number 66 34 633.
Z-0034-05	Siemens Medical Solutions USA, Inc	2	AXIOM Sensis Programmable diagnostic computer, Model number 66 34 641
Z-0035-05	Siemens Medical Solutions USA, Inc	2	AXIOM Sensis Programmable diagnostic computer, Model number 66 34 658

Similar Registrations

Registration Number	Establishment Name	Location
3020036682	CARDIONXT	Westminster, CO, US
3031786139	B-SECUR LIMITED	Belfast, GB
3042175841	PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.	Best Noord-Brabant, NL
3013300026	BIOSENSE WEBSTER, INC.	Irvine, CA, US
3003084417	STEREOTAXIS, INC.	Saint Louis, MO, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3017401510. Last updated year: 2026. Please use registration number 3017401510 when referencing this establishment in official correspondence.