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

    THE DENVER PLEURAL-PERITONEAL SHUNT

    K Number: K842139 · Decision Aug 27, 1984
    View on FDA
    Classifications
    1
    FEI Numbers
    7
    Registration Numbers
    7
    Same Product Code
    18
    Applicant Total
    10
    Review Days
    89

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    Basic Information

    Device Name
    THE DENVER PLEURAL-PERITONEAL SHUNT
    K Number
    K842139
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5955
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Applicant
    Denver Biomedicals, Inc.
    Date Received
    May 30, 1984
    Decision Date
    August 27, 1984
    Product Code
    KPM
    Advisory Committee
    Gastroenterology, Urology
    Review Advisory Committee
    GU
    Third Party
    N

    Classifications

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

    Product Code Device Name
    KPM Shunt, Peritoneal

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    Other Clearances by Denver Biomedicals, Inc.

    K Number Device Name
    K051084 DENVER PLEURX DRAINAGE KIT AND DENVER PLEURX VACUUM BOTTLE WITH DRAINAGE LINE
    K011020 DENVER PLEURAL EFFUSION SHUNT WITH EXTERNAL PUMP CHAMBER
    K010642 PLEURX PLEURAL CATHETER AND DRAINAGE KITS
    K003451 DENVER PAK W/ DOUBLE-VALVE ASCITES SHUNT,DENVER PAK W/ SINGLE-VALVED ASCITES SHUNT, DENVER PAK, DOUBLED-VALVED ASCITES T
    K943968 TUNNELER
    K913728 DENVER(R) PERITONEO-SUBCLAVIAN SHUNT
    K822686 DENVER PERITONEO-VENOUS SHUNT (DP-VS)
    K811577 CROUCH CORNEAL PROTECTOR
    K811183 DENVER PERITONEO-VENOUS SHUNT