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

    PROCEDURE PACKS PRESS. MONITOR/ADMINISTRATION LINE

    K Number: K882655 · Decision Sep 16, 1988
    View on FDA
    Classifications
    1
    FEI Numbers
    210
    Registration Numbers
    211
    Same Product Code
    499
    Applicant Total
    4
    Review Days
    79

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    Basic Information

    Device Name
    PROCEDURE PACKS PRESS. MONITOR/ADMINISTRATION LINE
    K Number
    K882655
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.1200
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Applicant
    Procedure Packs, Inc.
    Date Received
    June 29, 1988
    Decision Date
    September 16, 1988
    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 Procedure Packs, Inc.

    K Number Device Name
    K891572 ANGIOGRAPHY CUSTOM PACKS
    K882717 PROCEDURE PACKS CONTRAST MEDIA SETS
    K882716 PROCEDURE PACKS SOLUTION ADMINISTRATION SETS