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

    CATHETER, BETA-CAP-PERITONEAL

    K Number: K782058 · Decision Feb 27, 1979
    View on FDA
    Classifications
    1
    FEI Numbers
    26
    Registration Numbers
    26
    Same Product Code
    47
    Applicant Total
    16
    Review Days
    82

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    Basic Information

    Device Name
    CATHETER, BETA-CAP-PERITONEAL
    K Number
    K782058
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5630
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Applicant
    Dravon Medical, Inc.
    Date Received
    December 7, 1978
    Decision Date
    February 27, 1979
    Product Code
    FJS
    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
    FJS Catheter, Peritoneal, Long-Term Indwelling

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    Other Clearances by Dravon Medical, Inc.

    K Number Device Name
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    K831842 DRAVON T CLAMP
    K812771 PERITONEAL DIALYSIS DRAINAGE
    K812772 PERITONEAL DIALYSIS CYCLER SET (8UNIT)
    K811851 S-610 SHUNT ADAPTOR SET
    K800435 HEMOSTATIC/TUBE OCCLUDING FORCEPS
    K782057 CATHETER, RADIOPAQUE TENCKHOFF
    K781755 DAP-PAK
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