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Ep Technologies, Inc.

United StatesFDA 510(k) applicant, unverified

Devices
15

What Ep Technologies, Inc. makes

Ep Technologies, Inc. manufactures electrophysiology catheters, including steerable and diagnostic models such as the FRANZ™, STEEROCATH™, and POLARIS X series, as well as mapping and stimulation devices like the MAP DC-coupled preamplifier and constant current stimulator. Their portfolio also includes real-time position management systems for cardiac procedures and specialized catheters like the QUATTRO and TRACFINDER II.

The company’s devices are classified as Class II under FDA regulations and are supported by 510(k) clearance records. These products are listed in the FDA’s 510(k) database, reflecting their regulatory authorization for electrophysiology and related cardiac applications. The manufacturer operates from the United States.

AI-generated from registry data, 2 Oct 2026. Not verified by deviCERTS or the manufacturer.

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Frequently asked questions

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

The registry currently lists 15 devices for Ep Technologies, Inc.. Devices recorded under merged duplicate company entries are counted once.

Which registries list Ep Technologies, Inc.'s devices?

Among its 15 most recently registered devices, Ep Technologies, Inc. has devices listed in FDA 510(k) (15 devices).

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

Among its 15 most recently registered devices, the classes recorded for Ep Technologies, Inc.'s devices are Class II. Each device page shows its own class and authorisation.

What are the newest devices from Ep Technologies, Inc. in the registry?

The most recently registered devices listed for Ep Technologies, Inc. include MAP DC-COUPLED ISOLATED PREAMPLIFIER MODEL #1001, TRACFINDER II, FRANZ(TM) STEERABLE COMBINATION CATHETER and DIAGNOSTIC II CATHETER.

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