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Triple Jump Israel, Ltd.

IsraelFDA 510(k) applicant, unverified

Devices
1

What Triple Jump Israel, Ltd. makes

Triple Jump Israel, Ltd. manufactures the Inessa System, a medical device designed for minimally invasive cardiac procedures, including structural heart interventions.

The Inessa System is classified as a Class II device under FDA regulations and is listed in the FDA’s 510(k) registry. The company is based in the United States.

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

Catalogue1

Newest first, rows 1-1 of 1

  • Inessa System Ref K230545

    Class II
    Active 510(k) 510(k) II

Frequently asked questions

How many devices does Triple Jump Israel, Ltd. have in the registry?

The registry currently lists 1 device for Triple Jump Israel, Ltd.. Devices recorded under merged duplicate company entries are counted once.

Which registries list Triple Jump Israel, Ltd.'s devices?

Among its 1 most recently registered device, Triple Jump Israel, Ltd. has devices listed in FDA 510(k) (1 device).

What risk classes do Triple Jump Israel, Ltd.'s devices fall under?

Among its 1 most recently registered device, the classes recorded for Triple Jump Israel, Ltd.'s devices are Class II. Each device page shows its own class and authorisation.

What are the newest devices from Triple Jump Israel, Ltd. in the registry?

The most recently registered devices listed for Triple Jump Israel, Ltd. include Inessa System.

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