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Paieon, Inc.

Country not established

Devices
8

What Paieon, Inc. makes

Paieon, Inc. makes cardiopulmonary bypass systems and related components, including the CARDIOP-B SYSTEM and its variants with LVA, as well as the IC-PRO SYSTEM and its model versions, and the C-THV SYSTEM and CARDNAV devices.

These devices are classified as Class II medical devices and are listed in the FDA 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.

Catalogue8

Newest first, rows 1-8 of 8

  • Cardiop-B System, Version 2.1 Ref K072591

    Active Regimes: 510(k) Registry: 510(k) Class:II
  • C-Thv System Ref K113594

    Active Regimes: 510(k) Registry: 510(k) Class:II
  • Cardnav Ref K120282

    Active Regimes: 510(k) Registry: 510(k) Class:II
  • Cardiop-B System, Version 2.1 With Lva Ref K073328

    Active Regimes: 510(k) Registry: 510(k) Class:II
  • Ic-Pro System, Version 3.1.0.4 Ref K082907

    Active Regimes: 510(k) Registry: 510(k) Class:II
  • The Ic-Pro System, Model Version 3.2 Ref K083745

    Active Regimes: 510(k) Registry: 510(k) Class:II
  • The Ic-Pro System Ref K110256

    Active Regimes: 510(k) Registry: 510(k) Class:II
  • The Cardiop-B System Ref K030139

    Active Regimes: 510(k) Registry: 510(k) Class:II

Frequently asked questions

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

The registry currently lists 8 devices for Paieon, Inc.. Devices recorded under merged duplicate company entries are counted once.

Which registries list Paieon, Inc.'s devices?

Among its 8 most recently registered devices, Paieon, Inc. has devices listed in FDA 510(k) (8 devices).

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

Among its 8 most recently registered devices, the classes recorded for Paieon, Inc.'s devices are Class II. Each device page shows its own class and authorisation.

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

The most recently registered devices listed for Paieon, Inc. include CARDIOP-B SYSTEM, VERSION 2.1, C-THV SYSTEM, CARDNAV and CARDIOP-B SYSTEM, VERSION 2.1 WITH LVA.

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