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

    PLEURX PLEURAL CATHETER AND DRAINAGE KITS

    K Number: K010642 · Decision Mar 20, 2001
    View on FDA
    Classifications
    1
    FEI Numbers
    29
    Registration Numbers
    29
    Same Product Code
    18
    Applicant Total
    10
    Review Days
    15

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    Basic Information

    Device Name
    PLEURX PLEURAL CATHETER AND DRAINAGE KITS
    K Number
    K010642
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.5050
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Denver Biomedicals, Inc.
    Date Received
    March 5, 2001
    Decision Date
    March 20, 2001
    Product Code
    DWM
    Advisory Committee
    Cardiovascular
    Review Advisory Committee
    AN
    Third Party
    N

    Classifications

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

    Product Code Device Name
    DWM Apparatus, Suction, Patient Care

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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
    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
    K842139 THE DENVER PLEURAL-PERITONEAL SHUNT
    K822686 DENVER PERITONEO-VENOUS SHUNT (DP-VS)
    K811577 CROUCH CORNEAL PROTECTOR
    K811183 DENVER PERITONEO-VENOUS SHUNT