BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    IVR-SP CUSTOM ANGIOGRAPHY TRAY

    K Number: K870419 · Decision May 11, 1987
    View on FDA
    Classifications
    1
    FEI Numbers
    210
    Registration Numbers
    211
    Same Product Code
    499
    Applicant Total
    6
    Review Days
    97

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    Basic Information

    Device Name
    IVR-SP CUSTOM ANGIOGRAPHY TRAY
    K Number
    K870419
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.1200
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Applicant
    North Coast Medi-Tek
    Date Received
    February 3, 1987
    Decision Date
    May 11, 1987
    Product Code
    DQO
    Advisory Committee
    Cardiovascular
    Review Advisory Committee
    CV
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    DQO Catheter, Intravascular, Diagnostic

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    Other Clearances by North Coast Medi-Tek

    K Number Device Name
    K870420 PTC-6 AND PTC-8 PERCUTANEOUS CHOLANGIOGRAPHY
    K870416 LP EXTENSION SETS
    K870418 MYA-1 AND MYT-1 MYELOGRAM TRAY
    K870417 RCT-1, RCT-2, RCT-3 ARTHROGRAM TRAY
    K854095 BIOPSY TRAY I & II