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

    CATCO UROLOGICAL CATHETER

    K Number: K944782 · Decision Oct 13, 1994
    View on FDA
    Classifications
    1
    FEI Numbers
    86
    Registration Numbers
    86
    Same Product Code
    81
    Applicant Total
    12
    Review Days
    16

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    Basic Information

    Device Name
    CATCO UROLOGICAL CATHETER
    K Number
    K944782
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5130
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Catco Medical, Inc.
    Date Received
    September 27, 1994
    Decision Date
    October 13, 1994
    Product Code
    EZD
    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
    EZD Catheter, Straight

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    Other Clearances by Catco Medical, Inc.

    K Number Device Name
    K945728 CATCO THORACIC CATHETER
    K944368 CATCO SILICONE UMBILICAL VESSEL CATHETER
    K944367 CATCO POLYURETHANE UMBILICAL VESSEL CATHETER
    K944336 CATCO UMBILICAL VESSEL CATHETER
    K944410 CATCO SILICONE DUAL LUMEN UMBILICAL VESSEL CATHETER
    K944685 CATO FIRST PICC-DUAL LUMEN
    K944504 CATCO FIRST PICC
    K945012 CATCO NUTRITIONAL CATHETER
    K945258 CATCO URINARY COLLECTION KIT
    K945499 CATO FIRST PICC KIT
    Search all 12 clearances from Catco Medical, Inc. →