Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K093565
    Device Name
    PLEURAFLOW CATHETER SYSTEM
    Date Cleared
    2010-12-03

    (380 days)

    Product Code
    Regulation Number
    878.4780
    Why did this record match?
    Applicant Name (Manufacturer) :

    CLEAR CATHETER SYSTEMS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The PleuraFlow Catheter is indicated for use as an adjunctive device during open surgical procedures in order to prevent fluid accumulation within the operative site after closure of the surgical wound. The device is indicated for use in thoracic surgical procedures.
    Device Description
    The PleuraFlow Catheter System is comprised of a silicone drainage tube and a shuttle assembly and guide tube. The PleuraFlow drainage tube is 20 inches in length with graduated measurements in inches from the first side hole and will be available in standard sizes from 20Fr to 32Fr versions. There is a barium stripe in the tube to facilitate visualization. A connector at the proximal end of the device connects to a commercially available drainage system. Within the catheter is a tube clearance apparatus to facilitate clearing of the drainage tube. The tube clearance apparatus is composed of a PTFE-coated guide wire that has a loop set on its distal end, bent at a 90-degree angle. The clearance apparatus is sized such that it cannot exit the end of the drainage tube or the side holes. The tube clearance apparatus is magnetically driven by an attached internal magnet coupled to an external magnet contained within the shuttle assembly.
    Ask a Question

    Ask a specific question about this device

    Page 1 of 1