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Barrx Medical, Incorporated

United StatesFDA applicant, unverified

Devices
13

What Barrx Medical, Incorporated makes

Barrx Medical, Incorporated manufactures coagulation and ablation catheters, including the HALO360 and HALO360+ models, as well as associated energy generators like the HALO360 Energy Generator and HALOFLEX Energy Generator. Their portfolio also includes specialized catheters such as the HALO90 Coagulation Catheter and HALO Ablation Catheter, alongside components like sizing balloons and foot switches for complete coagulation systems. Modifications to existing HALO Coagulation Catheter models are also part of their offerings.

These devices are classified as Class II under FDA regulations and are recorded in the 510(k) clearance registry. The company is based in the United States.

AI-generated from registry data, 3 Oct 2026. Not verified by deviCERTS or the manufacturer.

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Frequently asked questions

How many devices does Barrx Medical, Incorporated have in the registry?

The registry currently lists 13 devices for Barrx Medical, Incorporated. Devices recorded under merged duplicate company entries are counted once.

Which registries list Barrx Medical, Incorporated's devices?

Among its 13 most recently registered devices, Barrx Medical, Incorporated has devices listed in FDA 510(k) (13 devices).

What risk classes do Barrx Medical, Incorporated's devices fall under?

Among its 13 most recently registered devices, the classes recorded for Barrx Medical, Incorporated's devices are Class II. Each device page shows its own class and authorisation.

What are the newest devices from Barrx Medical, Incorporated in the registry?

The most recently registered devices listed for Barrx Medical, Incorporated include BARRX MODELS HALO360 AND HALO360+ COAGULATION CATHETERS, BARRX HALO COAGULATION SYSTEM, BARRX HALO COAGULATION GENERATOR, BARRX COAGULATION CATHETER, MODELS 2200-115A, 1520F, MODIFICATION TO: HALO COAGULATION CATHETER, MODELS 32041-18, 32041-20, 32041-22, 32041-25, 32041-28, 32041-31, 32041-34 and HALO ABLATION CATHETER, MODEL 90-9100.

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