BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    DENVER PARACENTESIS NEEDLE(60-1200) DENVER PARACENTESIS NEEDLE WITH DRAINAGE LINE(60-1100) DENVER PARACENTESIS TRAY

    K Number: K960456 · Decision Apr 1, 1996
    View on FDA
    Classifications
    1
    FEI Numbers
    329
    Registration Numbers
    330
    Same Product Code
    61
    Applicant Total
    4
    Review Days
    62

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    Basic Information

    Device Name
    DENVER PARACENTESIS NEEDLE(60-1200) DENVER PARACENTESIS NEEDLE WITH DRAINAGE LINE(60-1100) DENVER PARACENTESIS TRAY
    K Number
    K960456
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    878.4800
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Denver Biomaterials, Inc.
    Date Received
    January 30, 1996
    Decision Date
    April 1, 1996
    Product Code
    KDD
    Advisory Committee
    General, Plastic Surgery
    Review Advisory Committee
    SU
    Third Party
    N

    Classifications

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

    Product Code Device Name
    KDD Kit, Surgical Instrument, Disposable

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    Other Clearances by Denver Biomaterials, Inc.

    K Number Device Name
    K973129 DENVER ASCITES SHUNTS, DENVER ASCITES SHUNT PERCUTANEOUS ACCESS KITS
    K971753 DENVER PLEURX PLEURAL CATHETER KIT, CATALOG NO. 50-7000, DENVER PLEURX HOME DRAINAGE KIT, CATALOG NO. 50-7500
    K962814 DENVER PLEURAL EFFUSION SHUNT WITH EXTERNAL PUMP CHAMBER