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

    AMER. PHARMASEAL SILICONIZED LATEX

    K Number: K841544 · Decision Jul 9, 1984
    View on FDA
    Classifications
    1
    FEI Numbers
    114
    Registration Numbers
    114
    Same Product Code
    237
    Applicant Total
    64
    Review Days
    84

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    Basic Information

    Device Name
    AMER. PHARMASEAL SILICONIZED LATEX
    K Number
    K841544
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5130
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Applicant
    American Pharmaseal Div. Ahsc
    Date Received
    April 16, 1984
    Decision Date
    July 9, 1984
    Product Code
    KOD
    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
    KOD Catheter, Urological

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    Other Clearances by American Pharmaseal Div. Ahsc

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    K873359 AIRLIFE VOLUME VENTI. CIRCUIT W/CLEAR CAP EX VALVE
    K872228 PHARMASEAL ALTERNATING PRESSURE PAD SYSTEM
    K872917 JINOTTI SUCTION/OXYGEN INSUFFLATION CATHETER
    K871429 ANTIMICROBIAL FOLEY CATHETER
    K871770 AMERICAN PHARMASEAL WOUND DRESSING
    K870387 EUROMEDICAL, ENDOSOFT ENDOTRACHEAL TUBE
    K870977 PHARMASEAL T TYPE THERMOCOUPLE 100% CATH./PROBE
    Search all 64 clearances from American Pharmaseal Div. Ahsc →