Search Filters

Search Results

Found 2 results

510(k) Data Aggregation

    K Number
    K070380
    Device Name
    PORTACLAMP FLEX
    Date Cleared
    2007-06-08

    (120 days)

    Product Code
    Regulation Number
    870.4450
    Why did this record match?
    Applicant Name (Manufacturer) :

    CARDIO LIFE RESEARCH, S.A.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Portaclamp® Flex is indicated to clamp the aorta during minimally invasive cardiac surgery implying the usage of an extra-corporeal circulation.
    Device Description
    The Portaclamp® Flex is an aortic clamping device composed of a detachable, reusable handle and a single-use, disposable clamp. It is designed to be used through a standard thoracic port to clamp the aorta during minimally invasive cardiac bypass procedures. The Portaclamp Flex consists of a flexible guide wire, two jaws that are passed over the guide wire and positioned on each side of the aorta, and a mandrel that is slid along the length of the jaws to compress the jaws and clamp the aorta.
    Ask a Question

    Ask a specific question about this device

    K Number
    K033085
    Device Name
    PORTACLAMP
    Date Cleared
    2004-04-27

    (211 days)

    Product Code
    Regulation Number
    870.4450
    Why did this record match?
    Applicant Name (Manufacturer) :

    CARDIO LIFE RESEARCH, S.A.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Portaclamp™ is indicated to clamp the aorta during minimally invasive cardiac surgery implying the usage of an extra-corporeal circulation.
    Device Description
    The Portaclamp™ is a disposable aortic clamping device that is designed to be used through a standard thoracic port to clamp the aorta during minimally invasive cardiac bypass procedures. The Portaclamp™ consists of a flexible guide wire, two jaws that are passed over the guide wire and positioned on each side of the aorta. and a mandrel that is slid along the length of the jaws to compress the jaws and clamp the aorta.
    Ask a Question

    Ask a specific question about this device

    Page 1 of 1