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510(k) Data Aggregation

    K Number
    K032888
    Device Name
    CREATION NM DIAGNOSTIC CATHETERS
    Manufacturer
    NEICH MEDICAL (SHENZHEN) COMPANY LIMITED
    Date Cleared
    2004-02-24

    (161 days)

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

    NEICH MEDICAL (SHENZHEN) COMPANY LIMITED

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Neich Modical Creation NM™ Diagnostic Catheters are designed to deliver radiopaque contrast thediturn to selected sites in the vascular system,
    Device Description
    Creation NM™ Diagnostic Catheter
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    K Number
    K030715
    Device Name
    SAFFRON NM GUIDING CATHETER
    Manufacturer
    NEICH MEDICAL (SHENZHEN) COMPANY LIMITED
    Date Cleared
    2003-04-24

    (48 days)

    Product Code
    DQY
    Regulation Number
    870.1250
    Why did this record match?
    Applicant Name (Manufacturer) :

    NEICH MEDICAL (SHENZHEN) COMPANY LIMITED

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Saffron NM™ Guiding Catheter is indicated for use for intravascular introduction of interventional/diagnostic devices into coronary or peripheral vascular systems.
    Device Description
    Not Found
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