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510(k) Data Aggregation

    K Number
    K080645
    Device Name
    STD MED PRIMO PORT POLY
    Manufacturer
    Date Cleared
    2008-05-02

    (57 days)

    Product Code
    Regulation Number
    880.5965
    Why did this record match?
    Applicant Name (Manufacturer) :

    STD MED, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The STD Med Primo Port is a totally-implantable vascular access device designed to provide long term, repeated access to the vascular system. The STD Med Primo Port Poly is indicated for patient therapies requiring repeated access to the vascular system. The port system can be used for infusion of medications, I.V. fluids, parenteral nutrition solutions, blood products, and for the withdrawal of blood samples.
    Device Description
    The device described in this 510(k) consists of a a modified sterile, single use, implantable port, with catheter and catheter locks. The port is introduced into the vascular system and attached to the port stem using a catheter lock. The port is then sutured under the skin in the area of the subclavian fossa. The port is accessed percutancously usina a non-coring needle that penetrates a silicone rubber septum at the top of the port. The port system is the mechanism with which fluids can pass into and out of the central venous system.
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    K Number
    K070911
    Device Name
    STD MED PRIMO PORT
    Manufacturer
    Date Cleared
    2007-08-10

    (130 days)

    Product Code
    Regulation Number
    880.5965
    Why did this record match?
    Applicant Name (Manufacturer) :

    STD MED, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The STD Med Primo Port is indicated for patient therapies requiring repeated access to the vascular system. The port system can be used for infusion of medications, I. V. fluids, parenteral nutrition solutions, blood products and for the withdrawal of blood samples.
    Device Description
    The STD Med Primo Port kit contains 1 Titanium port, 1 catheter of choice, and 2 corresponding catheter locks, The catheter is introduced into the vascular system and attached to the port stem using a catheter lock. The port is then sutured under the skin in area of the subclavian fossa. The port is accessed percutaneously using a noncoring needle that penetrates a silicone rubber septum at the top of the port. The port system is the mechanism with which fluids can pass into and out of the central venous system.
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    Ask a specific question about this device

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