Cardiotomy/Mediastinal Autotransfusion Reservoir

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K852382 ↗

FDA Product Code

DTN

Device Class

Class II

Regulation

21 CFR Part 870.4400

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

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  Class I

  FDA 510(k) K832411 Active Cleared 12 Sep 1983

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  Class II

  FDA 510(k) K852683 Active Cleared 12 Aug 1985

• Integrated Membrane Oxygenator W/Cardiotomy Filter

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• Adjustable Oxygenator Holder Model No. Bcm-Hl

  Class I

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• What is the Cardiotomy/Mediastinal Autotransfusion Reservoir used for in cardiac surgery?

  This device collects and temporarily stores blood and mediastinal fluids drained from a patient’s chest during cardiopulmonary bypass procedures. It ensures those fluids can be safely reinfused back into the patient’s circulatory system, helping to maintain blood volume and oxygenation during surgery.

• Is the Cardiotomy/Mediastinal Autotransfusion Reservoir intended for reuse or single-use?

  The device is explicitly designed for single-use only in sterile surgical settings, as specified in its description. Reuse is not recommended or supported by the manufacturer.

• What sizes or models of the Cardiotomy/Mediastinal Autotransfusion Reservoir are available?

  The provided data does not specify exact sizes or model variations, but the device is listed under FDA product code DTN and includes multiple registration numbers (e.g., 3030125051, 1000138054) which may correspond to different configurations or capacities. For precise sizing details, consult the manufacturer’s technical documentation or catalog.

• How should the Cardiotomy/Mediastinal Autotransfusion Reservoir be stored before use?

  Since it is a sterile, single-use device, storage instructions typically require keeping it in its original, sealed packaging in a clean, dry environment away from direct sunlight or extreme temperatures. Always follow the manufacturer’s specific storage guidelines included with the packaging to maintain sterility.

• What regulatory pathway was followed for FDA clearance of this device, and what does that mean for clinicians?

  The device received FDA 510(k) clearance (K852382) in 1985 under the Traditional 510(k) pathway, determined to be *substantially equivalent* to a predicate device. This means it was evaluated by the FDA’s Cardiovascular (CV) Advisory Committee and classified as a Class II device (regulation 870.4400). Clinicians can rely on this clearance as evidence of safety and performance for its intended use in cardiopulmonary bypass procedures.