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Cardio Tek, BV

Country not established FDA

Devices
2
Registrations
FDA
FDA recalls
2

At a glance

Counted by deviCERTS from registry records

Market reach

United States
FDA establishment, FDA recalls

What Cardio Tek, BV makes

Cardio Tek, BV manufactures the EP-TRACER System, a device used for electrophysiological mapping and catheter ablation procedures in cardiac electrophysiology.

The company’s portfolio is regulated under FDA’s Class II device classification and is listed in the FDA’s 510(k) clearance registry. The manufacturer is based in the United States.

AI-generated from registry data, 26 Oct 2026. Not verified by deviCERTS or the manufacturer.

Catalogue2

Newest first, rows 1-2 of 2

FDA recalls2

Recalls are matched to the firm by name. FDA recall data as of 22 Oct 2026.

FDA recall records list 2 recalls initiated by Cardio Tek, BV, the earliest on 2017-04-13 and the most recent on 2022-04-25. The reasons filed fall into these groups: software or firmware and electrical or power. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.

Generated automatically from FDA recall records, as a summary of the records listed below. It describes what the records state and is not an assessment of this manufacturer.

Recalls initiated per year

  • 2017 1
  • 2018 0
  • 2019 0
  • 2020 0
  • 2021 0
  • 2022 1
  • 2023 0
  • 2024 0
  • 2025 0
  • 2026 0

  • 2022

    • 25 Apr 2022 Z-1283-2022 Class II Completed Device did not pass electrical safety testing for adequate insulation. Distribution: Worldwide distribution - US Nationwide distribution in the states of CA, NY, NC and the countries of South Korea,…
      Full distribution text Worldwide distribution - US Nationwide distribution in the states of CA, NY, NC and the countries of South Korea, Mexico, Kazakhstan, Netherlands, Spain, Germany, Finland, Poland, Israel, Turkey, Chile, Ecuador, Austria, Croatia, Sweden, United Kingdom, Colombia, Italy, Portugal, Canada, Saudi Arabia, Belgium, Slovenia, Brazil, Hungary, Malaysia, Uzbekistan.
      Submission number: K183266

  • 2017

    • 13 Apr 2017 Z-2657-2017 Class II Completed Software bug which allows parameters to be changed unintentionally during use. Distribution: Worldwide Distribution: US (nationwide) to states of: CA, IL, OH, and MN; and countries of: Albania, Algeria, Argentina,…
      Full distribution text Worldwide Distribution: US (nationwide) to states of: CA, IL, OH, and MN; and countries of: Albania, Algeria, Argentina, Bangladesh, Belgium, Bolivia, Brazil, Canada, Chile, Colombia, Costa Rica, Croatia, Cuba, Czech Rep, Denmark, Ecuador, Egypt, Estonia, Finland, France, Georgia, Germany, Greece, Guatemala, Honduras, Hungary, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Jamaica, Jordan, Kosovo, Kuwait, Latvia, Lebanon, Libya, Lithuania, Malaysia, Malta, Mexico, Monaco, Morocco, Netherlands, Norway, Pakistan, Palestine, Peru, Philippines, Poland, Portugal, Rep. Dominicana, Romania, Russia, Saudi Arabia, Singapore, South Africa, Spain, Sri Lanka, Sweden, Switzerland, Syria, Trinidad & Tobago, Turkey, United Arab Emirates, United Kingdom, Venezuela and Vietnam.
      Submission numbers: K134044, K161245

FDA establishments1

Registered with the FDA under this company group, matched by name.

  • Cardiotek BV GL SIttard Limburg · NL FEI 3008329188

Frequently asked questions

How many devices does Cardio Tek, BV have in the registry?

The registry currently lists 2 devices for Cardio Tek, BV. Devices recorded under merged duplicate company entries are counted once.

Which registries list Cardio Tek, BV's devices?

Among its 2 most recently registered devices, Cardio Tek, BV has devices listed in FDA 510(k) (2 devices).

What risk classes do Cardio Tek, BV's devices fall under?

Among its 2 most recently registered devices, the classes recorded for Cardio Tek, BV's devices are Class II. Each device page shows its own class and authorisation.

Are there FDA recall records for Cardio Tek, BV?

FDA recall records list 2 recalls initiated by Cardio Tek, BV, the most recent initiated on 2022-04-25. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.

What are the newest devices from Cardio Tek, BV in the registry?

The most recently registered devices listed for Cardio Tek, BV include EP-TRACER System and EP-TRACER SYSTEM, EP-TRACER SYSTEM, EP-TRACER SYSTEM.

Which FDA establishments are linked to Cardio Tek, BV?

1 FDA establishment is linked to Cardio Tek, BV in the registry; they are listed on the company page.

Generated automatically from registry data and not verified by a human reviewer.