Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3008329188

FEI Number

3008329188

Entity Name

CARDIOTEK BV

City/State/Country

GL SIttard Limburg, NL

Establishment Address

Dr. Nolenslaan 107B, GL SIttard Limburg 6136, NL

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Schwarzer Cardiotek GmbH (Owner Number: 10048719)

Owner / Operator Contact Address

Im Zukunftspark 3, Heilbronn, DE-BW 74076, DE

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K183266

PMA Number

N/A

All Registered Proprietary Names

EP-Tracer System EP-TRACER

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
DQK	Computer, Diagnostic, Programmable	Cardiovascular	Class 2	870.1425	2018-12-04
DQK	Computer, Diagnostic, Programmable	Cardiovascular	Class 2	870.1425	2019-07-01

Official Correspondent

Fritz Vollmer

US Agent Details

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

Related Public Records

Same Entity

Schwarzer Cardiotek GmbH

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 3008329188. Last updated year: 2026. Please use registration number 3008329188 when referencing this establishment in official correspondence.