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510(k) Data Aggregation

    K Number
    K122263
    Device Name
    14.5-16.0 FRENCH CUFFED CATHETER REMOVAL DEVICE, SYMMETRY SURGICAL SINGEL USE
    Manufacturer
    Date Cleared
    2012-09-28

    (63 days)

    Product Code
    Regulation Number
    880.5970
    Why did this record match?
    Product Code :

    ODY

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Symmetry Surgical Single Use Cuffed Catheter Removal Device is a catheter accessory device intended for the minimally invasive removal of tunneled long term catheters. The Cuffed Catheter Removal Device is indicated for use with tunneled, double lumen Permcath catheters with sizes ranging from 6.0 French to 16.0 French
    Device Description
    Symmetry Surgical Single Use Cuffed Catheter Removal devices are sold as sterile, single use devices, unless otherwise noted. The Symmetry Surgical Single Use Cuffed Catheter Removal Device is a tool for minimizing surgical trauma associated with catheter removal. The device jaws are normally in the closed position. The device is equipped with a trigger, a button located on the handle, actuated feature that opens the jaws. Upon release of the trigger, the jaws return to the normally closed position with a spring assist mechanism. The Single Use Cuffed Catheter Removal Device has no locking mechanism. During use the jaws are opened outside the patient and allowed to close around the catheter. The catheter then serves as a guide for moving the closed tip down into the catheter tunnel. When cutting the catheter cuff, the jaws may be activated to allow for tissue dissection and release which will then ease the catheter removal. The opening of the jaws in vivo are limited by the constraint of the surrounding tissue tunnel as well as the design limit of no more than a maximum angle of 57°.
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    K Number
    K063048
    Device Name
    TRANS-CATHETER EXTRACTOR
    Manufacturer
    Date Cleared
    2007-09-14

    (345 days)

    Product Code
    Regulation Number
    880.5970
    Why did this record match?
    Product Code :

    ODY

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Trans Catheter Extractor is a catheter accessory device intended for minimally invasive removal of tunneled long term catheters. The Trans Catheter Extractor is indicated for use with tunneled, double lumen Permcath catheters with cuff sizes ranging from 10.8 french to 14.5 french.
    Device Description
    The Trans Catheter Extractor is a catheter accessory device intended for minimally invasive removal of tunneled long term catheters.
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