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510(k) Data Aggregation

    K Number
    K011783
    Device Name
    MULTI-SNARE SET
    Manufacturer
    PFM PRODUKTE FUR DIE MEDIZIN AG
    Date Cleared
    2002-01-24

    (231 days)

    Product Code
    DXE
    Regulation Number
    870.5150
    Why did this record match?
    Applicant Name (Manufacturer) :

    PFM PRODUKTE FUR DIE MEDIZIN AG

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Multi-Snare Set (and its components) is intended for: Retrieval and manipulation of foreign objects from the vascular system and hollow viscera Assistance in creating loops where cross-over technique is applied Repositioning of indwelling venous catheters Assistance in performing venipuncture to obtain access to central vein
    Device Description
    The pfm Multi-Snare Set is contains of the following parts: - Inner wire which forms the loop; - Coil mounted on the inner wire in the loop section; - Shaft body consisting of an outside coil and a core wire; and - Transition from loop wire to shaft body. The Multi-Snare Set consists of a highly elastic Nitinol wire with a pre-formed loop on its distal end. The ware of the snare's highly elastic design, the snare can be introduced through an insertion sheath. The diameter of the snare can be adjusted depending on the position of the sheath. For better manipulation and torque-ability a torquer is provided. The introducer sheath is designed for interventional insertion of instruments and systems into the vascular system. The insertion sheath consists of polyethylene tubing, which is curved at its distal end and has a luer adapter at its proximal end. For better visualization the introducer sheath has an additional distal radiopaque marker.
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    K Number
    K002471
    Device Name
    JETCAN HUBER NEEEDLE SET
    Manufacturer
    PFM PRODUKTE FUR DIE MEDIZIN AG
    Date Cleared
    2000-10-19

    (69 days)

    Product Code
    FPA
    Regulation Number
    880.5440
    Why did this record match?
    Applicant Name (Manufacturer) :

    PFM PRODUKTE FUR DIE MEDIZIN AG

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K001716
    Device Name
    REDON SET
    Manufacturer
    PFM PRODUKTE FUR DIE MEDIZIN AG
    Date Cleared
    2000-07-19

    (44 days)

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

    PFM PRODUKTE FUR DIE MEDIZIN AG

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
    Ask a Question

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