Argyle Aqua-Seal All Purpose Autotransfusion Chest Drainage Unit

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

Full name

Argyle Aqua-Seal All Purpose Autotransfusion Chest Drainage Unit and Optional Argyle Aqua-Seal Evacuating Autotransfusio

510(k) Number

K970857 ↗

FDA Product Code

CAC

Device Class

Class II

Regulation

21 CFR Part 868.5830

Advisory Committee

Anesthesiology

FDA Decision

SESE Substantially Equivalent

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See all devices from Davis & Geck, Inc. →

• What is the Argyle Aqua-Seal All Purpose Autotransfusion Chest Drainage Unit designed for?

  This device is specifically designed for autotransfusion and pleural space management during thoracic drainage procedures. It collects autologous blood from the pleural cavity and reinfuses it, helping to restore negative pressure while reducing blood loss. This makes it ideal for use in operating rooms and critical care settings where precise fluid control is required.

• Is the Argyle Aqua-Seal All Purpose Autotransfusion Chest Drainage Unit single-use or reusable?

  The Argyle Aqua-Seal All Purpose Autotransfusion Chest Drainage Unit is a reusable medical device. It is intended to be used in sterile environments such as operating rooms and critical care settings, where proper cleaning and reprocessing protocols are followed to maintain safety and functionality.

• What sizes or configurations are available for this device?

  This device is available in multiple sizes and configurations, each referenced by specific product codes such as CAC. The exact configuration or size should be selected based on the clinical requirements and the specific procedure being performed, ensuring compatibility with the patient’s needs and the intended use.

• How should the Argyle Aqua-Seal All Purpose Autotransfusion Chest Drainage Unit be stored?

  Since this device is reusable, it must be stored in a clean, dry environment when not in use. Proper storage includes keeping it in its original packaging or a designated storage area to prevent contamination. Before each use, the device must undergo thorough cleaning and sterilization as per manufacturer guidelines to ensure sterility and functionality.

• What regulatory pathway does this device follow?

  The Argyle Aqua-Seal All Purpose Autotransfusion Chest Drainage Unit is regulated under the FDA 510(k) clearance pathway, with a classification of Class II. It was cleared under the reference number K970857 and is intended for use in settings where sterile conditions are maintained, such as operating rooms and critical care units.