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

    MEGA ANGIOGRAM KIT

    K Number: K913397 · Decision Oct 31, 1991
    View on FDA
    Classifications
    1
    FEI Numbers
    210
    Registration Numbers
    211
    Same Product Code
    499
    Applicant Total
    7
    Review Days
    93

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    Basic Information

    Device Name
    MEGA ANGIOGRAM KIT
    K Number
    K913397
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.1200
    Medical Specialty
    Cardiovascular
    Decision
    Unknown
    Statement or Summary
    Statement
    Applicant
    Mega Medical, Inc.
    Date Received
    July 30, 1991
    Decision Date
    October 31, 1991
    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 Mega Medical, Inc.

    K Number Device Name
    K915863 MEGA AMNIOCENTESIS KIT
    K913317 MEGA ARTHROGRAM KIT
    K912445 MEGA CONTINUOUS EPIDURAL ANESTHESIA KIT
    K913382 MEGA PARACENTESIS KIT
    K912322 MEGA SPINAL ANESTHESIA KIT
    K912564 MEGA PERICARDIOCENTESIS KIT