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

    MEDCOMP P-CATH

    K Number: K953811 · Decision Jul 25, 1996
    View on FDA
    Classifications
    1
    FEI Numbers
    204
    Registration Numbers
    205
    Same Product Code
    503
    Applicant Total
    40
    Review Days
    365

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    Basic Information

    Device Name
    MEDCOMP P-CATH
    K Number
    K953811
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.5200
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Medcomp
    Date Received
    July 26, 1995
    Decision Date
    July 25, 1996
    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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    K091954 MICRO-STICK SET
    K092347 PRO-PICC CT
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    K090394 VALVED TEARWAY INTRODUCER
    K091586 VASCU-PICC AND MIDLINE CATHETERS, SINGLE, DOUBLE AND TRIPLE LUMEN
    K091466 1.9F X 20CM VASCU-PICC, 1.9F X 50CM VASCU-PICC, MODEL VPI.9S20, VPI.9S50
    K081775 THE MEDCOMP .010 VASCULAR GUIDEWIRES
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