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

    MEGA PERICARDIOCENTESIS KIT

    K Number: K912564 · Decision Sep 5, 1991
    View on FDA
    Classifications
    1
    FEI Numbers
    276
    Registration Numbers
    277
    Same Product Code
    889
    Applicant Total
    7
    Review Days
    86

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    Basic Information

    Device Name
    MEGA PERICARDIOCENTESIS KIT
    K Number
    K912564
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.1250
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Mega Medical, Inc.
    Date Received
    June 11, 1991
    Decision Date
    September 5, 1991
    Product Code
    DQY
    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
    DQY Catheter, Percutaneous

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    Other Clearances by Mega Medical, Inc.

    K Number Device Name
    K915863 MEGA AMNIOCENTESIS KIT
    K913317 MEGA ARTHROGRAM KIT
    K913397 MEGA ANGIOGRAM KIT
    K912445 MEGA CONTINUOUS EPIDURAL ANESTHESIA KIT
    K913382 MEGA PARACENTESIS KIT
    K912322 MEGA SPINAL ANESTHESIA KIT