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

    GESCO DUAL LUMEN PER-Q-CATH-DL

    K Number: K895942 · Decision Jul 2, 1990
    View on FDA
    Classifications
    1
    FEI Numbers
    204
    Registration Numbers
    205
    Same Product Code
    503
    Applicant Total
    26
    Review Days
    264

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    Basic Information

    Device Name
    GESCO DUAL LUMEN PER-Q-CATH-DL
    K Number
    K895942
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.5200
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Applicant
    Gesco Intl., Inc.
    Date Received
    October 11, 1989
    Decision Date
    July 2, 1990
    Product Code
    FOZ
    Advisory Committee
    General Hospital
    Review Advisory Committee
    HO
    Third Party
    N

    Classifications

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

    Product Code Device Name
    FOZ Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days

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    Other Clearances by Gesco Intl., Inc.

    K Number Device Name
    K954422 PER-Q-CATH MID-LINE
    K940953 UMBILI-CATH-S
    K940870 UMBILI-CATH
    K940952 UMBILI-CATH-S-DL
    K941672 URI-CATH CATHETER
    K941232 THORA-CATH
    K940871 UMBILI-CATH-P
    K931989 VENTRI-CATH
    K926063 PER-Q-CATH DRESSING CHANGE TRAY
    K923591 PALA-NATE
    Search all 26 clearances from Gesco Intl., Inc. →