Data / Medical devices / Netherlands / Cardiotek BV
Cardiotek BV: FDA-registered device maker in GL SIttard Limburg, Netherlands, 3 510(k) clearances
Cardiotek BV is registered with the FDA (registration 3008329188) in GL SIttard Limburg, Netherlands. It lists 1 device type. The FDA files 3 510(k) clearances under its listings, the newest dated March 1, 2019. 2 recall events name it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3008329188
- Address
- Dr. Nolenslaan 107B, GL SIttard Limburg, Netherlands, 6136
- Owner or operator
- Schwarzer Cardiotek GmbH (10048719)
- Roles
- Manufacturer
- First device listed
- February 17, 2015
- Registered through
- 2026
- Brand names listed
- EP Tracer, EP-TRACER, EP-Tracer System
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Computer, Diagnostic, Programmable | DQK | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| March 1, 2019 | K183266 | EP-TRACER System | DQK | Substantially Equivalent | Schwarzer Cardiotek GmbH | accessdata.fda.gov |
| August 5, 2016 | K161245 | EP-TRACER System | DQK | Substantially Equivalent | Cardio Tek, BV | accessdata.fda.gov |
| March 31, 2014 | K134044 | EP-TRACER SYSTEM, EP-TRACER SYSTEM, EP-TRACER SYSTEM | DQK | Substantially Equivalent | Cardio Tek, BV | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| April 25, 2022 | 90154 | Class II | Completed | CardioTek EP-TRACER Software V2.x. | Device did not pass electrical safety testing for adequate insulation. | accessdata.fda.gov |
| April 13, 2017 | 77025 | Class II | Completed | CardioTek EP-TRACER Software V1.x and V2.0 The EP-TRACER System is an electrophysiology measurement system used to acquire, filter, digitize, amplify, display, and record signals obtained during electrophysiological stud | Software bug which allows parameters to be changed unintentionally during use. | accessdata.fda.gov |
Compare with other makers
Updated March 1, 2019. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.