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510(k) Data Aggregation

    K Number
    K960801
    Device Name
    SELECTOR ANGIOGRAPHIC CATHETER (VARIOUS MODELS)
    Date Cleared
    1996-03-29

    (31 days)

    Product Code
    Regulation Number
    870.1200
    Why did this record match?
    Applicant Name (Manufacturer) :

    NORTH AMERICAN INSTRUMENT CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Selector Angiographic Catheter is intended to deliver contrast medium during angiography as well as to provide a conduit for various diagnostic and therapeutic procedures. Selector Angiographic Catheters are intended for single-patient use only.
    Device Description
    The Selector Angiographic Catheter consists of a radiopaque shaft with an attached molded female luer lock hub. The shaft of the catheter includes a flexible section and an optional soft distal tip. The Selector Angiographic catheter may vary with respect to length, diameter, curve style, and the number of side holes present. Selector Angiographic Catheters can be introduced into the selected blood vessel by either cutdown or percutaneous entry techniques.
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    K Number
    K955554
    Device Name
    HEMO-VALVE
    Date Cleared
    1996-03-04

    (90 days)

    Product Code
    Regulation Number
    870.4290
    Why did this record match?
    Applicant Name (Manufacturer) :

    NORTH AMERICAN INSTRUMENT CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The HEMO-Valve is recommended for use in angiographic procedures involving blood or other potentially infectious materials, so that the procedure can be performed in such a manner as to minimize blood loss and patient/user exposure to these substances. The HEMO-Valve is intended for use in intra-arterial and intravenous administration of fluids, including radiographic contrast media.
    Device Description
    The HEMO-Valve consists of an elastomeric valve located between male and female luer lock fittings. The valve may be opened by connecting a male luer lock (the luer fitting pushes the gland out of the way) or may be opened by introducing a guidewire in a forward or backloading manner.
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    K Number
    K960310
    Device Name
    EPIC INTRODUCER SHEATH
    Date Cleared
    1996-02-07

    (16 days)

    Product Code
    Regulation Number
    870.1340
    Why did this record match?
    Applicant Name (Manufacturer) :

    NORTH AMERICAN INSTRUMENT CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Device Description
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