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

    CATCO POLYURETHANE UMBILICAL VESSEL CATHETER

    K Number: K944367 · Decision Apr 5, 1995
    View on FDA
    Classifications
    1
    FEI Numbers
    204
    Registration Numbers
    205
    Same Product Code
    503
    Applicant Total
    12
    Review Days
    210

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    Basic Information

    Device Name
    CATCO POLYURETHANE UMBILICAL VESSEL CATHETER
    K Number
    K944367
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.5200
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Catco Medical, Inc.
    Date Received
    September 7, 1994
    Decision Date
    April 5, 1995
    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 Catco Medical, Inc.

    K Number Device Name
    K945728 CATCO THORACIC CATHETER
    K944368 CATCO SILICONE 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
    K945727 CATCO NEONATAL PALATE GUARD
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