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Coratomic, Inc.

United StatesFDA applicant, unverified

Devices
15

What Coratomic, Inc. makes

Coratomic, Inc. manufactures endocardial pacing electrodes, including the ENDO-LOK L-40, L-15T, L-12, L-21, and L-22 models, designed for cardiac pacing applications. The company also produces pulse generators such as the VX5-105 and VX5-205, as well as cardiac pacemakers like the C-L0L. Additional products include the OVALITH-920, OVALITH-920BP, OVALITH-300, and OVALITH-10BP, which appear to be specialized pacing leads or electrode systems.

These devices fall under Class III regulatory classification in the US, requiring premarket approval (PMA) or a 510(k) clearance for market authorization. The products are listed in the FDA’s 510(k) registry, indicating compliance with US regulatory requirements. The manufacturer is based in the United States.

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

Catalogue15

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  • Endo-Lok L-40 Endocardial Pacing Elect. Ref K760714

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

  • Coratomic #VX5-105 & VX5-205 Pulse Gen. Ref K822791

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

  • L-15T Endocardial Pacing Electrode Ref K802689

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

  • Coratomic Model Ovalith-920 Ref K810808

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

  • Coratomic Model Ovalith-920 Ref K821033

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

  • Endocardial Pacing Electrode Ref K772309

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

  • Ovalith-300 Ref K790446

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

  • C-L0L Cardiac Pacemaker Ref K770559

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

  • Coratomic Model Ovalith 920BP Ref K821014

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

  • L-12, L-21, And L-22 Electrodes Ref K780569

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

  • Ovalith 10BP Ref K781377

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

  • Modification Of Sterility Cycle Parameters Ref K863365

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

  • L-501 Cardiac Pacemaker Ref K771992

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

  • Ovalith P-Bp Bipolar Cardiac Pacemaker Ref K800194

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

  • C-101-P Ref K820939

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

Rows 1-15 of 15

Frequently asked questions

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

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

Which registries list Coratomic, Inc.'s devices?

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

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

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

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

The most recently registered devices listed for Coratomic, Inc. include ENDO-LOK L-40 ENDOCARDIAL PACING ELECT., CORATOMIC #VX5-105 & VX5-205 PULSE GEN., L-15T ENDOCARDIAL PACING ELECTRODE and CORATOMIC MODEL OVALITH-920.

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