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Cardiothoracic Systems, Inc.

Also registered as Cardio Thoracic Systems

United StatesFDA applicant, unverified

Devices
11

What Cardiothoracic Systems, Inc. makes

Cardiothoracic Systems, Inc. manufactures surgical instruments and devices for coronary artery bypass procedures, including coronary shunts, cannulas, and bipolar scissors. Their portfolio also includes a balloon positioner for heart-lift applications and a blower/mister for surgical site preparation. These products are designed for use in minimally invasive and open-heart surgeries.

The company’s devices are classified under FDA categories Class I and Class II, with regulatory submissions recorded in the FDA 510(k) database. Their products are listed in the US under the jurisdiction of the Food and Drug Administration.

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

Catalogue11

Newest first, rows 1-11 of 11

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  • Guidant Axius Coronary Shunt Ref K010117

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

  • Voyager Quad Cannula Ref K983270

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

  • Acier Sutures Ref K991073

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

  • Cts Midcab Fixedn Diameter Coronary Shunt Ref K970638

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

  • Heart-Lift Balloon Positioner Ref K982419

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

  • Blower/Mister Ref K983135

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

  • Cts Midcab Stitcher Ref K963965

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

  • Deknatel Gwathmey Vascular Stapling Kit (Tenative) Ref K864146

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

  • Vacuum Assist Stabilizer Ref K992833

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

  • Cts Midcab Coronary Shunt Ref K963503

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

  • Cts Midcab/Svh Bipolar Scissors Ref K963930

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

Rows 1-11 of 11

Frequently asked questions

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

The registry currently lists 11 devices for Cardiothoracic Systems, Inc.. Devices recorded under merged duplicate company entries are counted once.

Which registries list Cardiothoracic Systems, Inc.'s devices?

Among its 11 most recently registered devices, Cardiothoracic Systems, Inc. has devices listed in FDA 510(k) (11 devices).

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

Among its 11 most recently registered devices, the classes recorded for Cardiothoracic Systems, Inc.'s devices are Class I and Class II. Each device page shows its own class and authorisation.

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

The most recently registered devices listed for Cardiothoracic Systems, Inc. include GUIDANT AXIUS CORONARY SHUNT, VOYAGER QUAD CANNULA, ACIER SUTURES and CTS MIDCAB FIXEDN DIAMETER CORONARY SHUNT.

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