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510(k) Data Aggregation

    K Number
    K983940
    Device Name
    EZ-INTRO PERCUTANEOUS CATHETER SHEATH, EZ-INTRO VESSEL DILATOR
    Manufacturer
    ADAM SPENCE CORP.
    Date Cleared
    1999-07-15

    (252 days)

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

    ADAM SPENCE CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Adam Spence Percutaneous Catheter Introducer is intended to provide a means for percutaneous vascular access while minimizing the back flow of blood during the introduction of cardiovascular devices such as catheters and guide wires.
    Device Description
    The Adam Spence Corp. Percutaneous Catheter Introducer (PCI) is a disposable device intended for use in diagnostic angiographic procedures.
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    K Number
    K955111
    Device Name
    MAXI-TORQUE PLUS ANGIOGRAPHIC CATHETER
    Manufacturer
    ADAM SPENCE CORP.
    Date Cleared
    1996-01-31

    (84 days)

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

    ADAM SPENCE CORP.

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