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

    THORA-CATH

    K Number: K941232 · Decision May 11, 1994
    View on FDA
    Classifications
    1
    FEI Numbers
    331
    Registration Numbers
    331
    Same Product Code
    83
    Applicant Total
    26
    Review Days
    57

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    Basic Information

    Device Name
    THORA-CATH
    K Number
    K941232
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.6740
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Gesco Intl., Inc.
    Date Received
    March 15, 1994
    Decision Date
    May 11, 1994
    Product Code
    JOL
    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
    JOL Catheter And Tip, Suction

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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
    K940871 UMBILI-CATH-P
    K931989 VENTRI-CATH
    K926063 PER-Q-CATH DRESSING CHANGE TRAY
    K923591 PALA-NATE
    K915167 GESCO PER-Q-CATH CATHETER INTRODUCER
    Search all 26 clearances from Gesco Intl., Inc. →