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510(k) Data Aggregation
K Number
K181667Device Name
Thoraguard System
Manufacturer
Date Cleared
2018-11-29
(157 days)
Product Code
Regulation Number
878.4780Why did this record match?
Applicant Name (Manufacturer) :
Centese, Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Thoraguard System is intended to be used for aspiration and removal of surgical fluids, tissue, gases, bodily fluids or infectious materials. The Thoraguard System is indicated for all situations where chest drains are applied - especially for thoracic drainage in the pleural and mediastinal cavity in situations such as pneumothorax, after cardiac or thoracic surgery (post-operative), thorax injury, pleural effusion, pleural empyema or other related conditions. The Thoraguard System is intended for use on patients in appropriate care settings.
Device Description
The Thoraguard Surgical Drainage System is an AC/DC powered suction pump designed for the aspiration and removal of surgical fluids, tissue, gases, bodily fluids or infectious materials. The Thoraguard System offers automated drainage functionality, acquisition and display of drainage information, and safety alarms associated with changes in patient output.
The Thoraguard System consists of the three sub-systems: the Thoraguard Control Module, a reusable electronic device for generating and regulating suction; the Thoraguard Drainage Kit, a disposable drainage canister and dual lumen drainage tubing set; and the Thoraguard Chest Tube Kit, a dual lumen drainage catheter with a passive valve and filter.
Similar to traditional chest drainage systems, the Thoraguard System drains accumulated blood and fluid through the chest tube using regulated suction. The control module facilitates this drainage automatically and works in conjunction with the drainage kit to function as a powered suction pump. The system may be used with any drainage catheter; when used with the Thoraguard Chest Tube Kit, the system provides automated clearance of clogs within the chest tube itself. During normal operation, the control module displays relevant system information via the touchscreen graphical user interface.
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