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Cardima, Inc.

United StatesFDA applicant, unverified

Devices
12
FDA recalls
2

At a glance

Counted by deviCERTS from registry records

Market reach

United States
FDA recalls

What Cardima, Inc. makes

Cardima, Inc. manufactures coronary sinus occlusion balloons, deflectable tip guiding catheters, and mapping devices for cardiac procedures, including microcatheters and electrode switchboxes. Their portfolio also includes ablation systems, infusion catheters, and specialized guidewires designed for electrophysiological studies and catheter-based interventions. The company produces tools for precise catheter navigation, such as the Pathfinder mapping microcatheters and the Tracer mapping device, as well as modifications to existing ablation systems.

The company’s devices are classified under Class II by the FDA and are listed under the 510(k) clearance process. Their products are intended for use in the United States, where regulatory compliance follows FDA guidelines for medical devices. No additional international registries or classifications are specified.

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

Catalogue12

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Rows 1-12 of 12

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 Cardima, Inc., initiated on 2010-05-20. By recorded status: 2 terminated. The reasons filed fall into these groups: sterility or contamination and packaging. 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.

  • 2010

    • 20 May 2010 Z-2580-2010 Unclassified (pre-2012) Terminated Sterility compromised-- The sterile pouch in which the product is packaged may be compromised, which could result in patient infection. Distribution: Worldwide Distribution to Distributors in USA (Pittsburgh, PA) and the countries of Ireland and Belgium, and customers…
      Full distribution text Worldwide Distribution to Distributors in USA (Pittsburgh, PA) and the countries of Ireland and Belgium, and customers in the states of CA, OH, MI, MO, AND WA, and the countries of Ireland and the Netherlands.
      Submission numbers: K022008, K060715
    • 20 May 2010 Z-2581-2010 Unclassified (pre-2012) Terminated Sterility compromised-- The sterile pouch in which the product is packaged may be compromised, which could result in patient infection. Distribution: Worldwide Distribution to Distributors in USA (Pittsburgh, PA) and the countries of Ireland and Belgium, and customers…
      Full distribution text Worldwide Distribution to Distributors in USA (Pittsburgh, PA) and the countries of Ireland and Belgium, and customers in the states of CA, OH, MI, MO, AND WA, and the countries of Ireland and the Netherlands.
      Submission numbers: K022008, K060715

Frequently asked questions

How many devices does Cardima, Inc. have in the registry?

The registry currently lists 12 devices for Cardima, Inc.. Devices recorded under merged duplicate company entries are counted once.

Which registries list Cardima, Inc.'s devices?

Among its 12 most recently registered devices, Cardima, Inc. has devices listed in FDA 510(k) (12 devices).

What risk classes do Cardima, Inc.'s devices fall under?

Among its 12 most recently registered devices, the classes recorded for Cardima, Inc.'s devices are Class II. Each device page shows its own class and authorisation.

Are there FDA recall records for Cardima, Inc.?

FDA recall records list 2 recalls initiated by Cardima, Inc., the most recent initiated on 20 May 2010. 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 Cardima, Inc. in the registry?

The most recently registered devices listed for Cardima, Inc. include CARDIMA VUEPORT CORONARY SINUS BALLOON OCCLUSION GUIDING CATHETER, NAVIPORT DEFLECTABLE TIP GUIDING CATHETER, TRACER O-T-W MAPPING DEVICE and ELECTRODE SWITCHBOX, MODEL 11-081002.

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