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510(k) Data Aggregation

    K Number
    K102048
    Device Name
    ATRAUMATIC VASCULAR CLAMPS
    Date Cleared
    2010-11-09

    (111 days)

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

    **GEOMED MEDIZIN- TECHNIK GMBH **& CO

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    GEOMED Vascular Clamps are intended for use for temporary occlusion of blood vessels during surgical procedures.
    Device Description
    The GEOMED Vascular Clamps are reusable devices and provided non sterile. They must be thoroughly cleaned and sterilized before use. GEOMED Vascular Clamps are made of Stainless Steel (following ASTM F 899-07). They are provided with ring handles and ratchet closures to adjust the amount of tension applied to the vessel for occlusion or partial occlusion. The GEOMED Vascular Clamps are available in a wide variety of shapes, sizes and lengths to accomodate to the individual needs of the surgeon. Based on the anatomy of the site, the surgical technique chosen, the size and type of blood vessel and occlusion desired, the surgeon decides which clamp to use. During surgery the handles and shanks need to be out of the field of vision of the operative site and therefore a wide variety of instrument figures and sizes is necessary. The Vascular Clamps occlude the arteries or veins with a tension that intends to produce minimal trauma to the vessels. They cover the vessel and stop the blood flow.
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