LogoFDA 510(k) Search
Search Filters

Search Results

Found 2 results

510(k) Data Aggregation

    K Number
    K972655
    Device Name
    CONTROL SYRINGE
    Manufacturer
    MEDICAL SPECIALTIES INTL., INC.
    Date Cleared
    1997-11-04

    (112 days)

    Product Code
    IZI
    Regulation Number
    892.1600
    Why did this record match?
    Applicant Name (Manufacturer) :

    MEDICAL SPECIALTIES INTL., INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    This device is used when viscous liquid needs to be hand-force injected into a manifold or tubing set. The polycarbonate housing enables pressure to be exerted without fear of breakage. nowsing charice problams of so so catheterization procedure.
    Device Description
    Control Syringe Models 10200, 10201, 10202, 10203, 10204 and 10205
    Ask a Question

    Ask a specific question about this device

    K Number
    K972654
    Device Name
    MANIFOLD
    Manufacturer
    MEDICAL SPECIALTIES INTL., INC.
    Date Cleared
    1997-10-08

    (85 days)

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

    MEDICAL SPECIALTIES INTL., INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The intended use is to direct the flow of fluids, via the stopcock arrangement, into tubing, catheters and collection systems during a heart catheterization procedure.
    Device Description
    Manifold
    Ask a Question

    Ask a specific question about this device

    Page 1 of 1