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

    ANTIMICROBIAL FOLEY CATHETER

    K Number: K871429 · Decision Aug 10, 1987
    View on FDA
    Classifications
    1
    FEI Numbers
    114
    Registration Numbers
    114
    Same Product Code
    237
    Applicant Total
    64
    Review Days
    123

    Research this 510(k) in seconds

    The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Device Name
    ANTIMICROBIAL FOLEY CATHETER
    K Number
    K871429
    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 9, 1987
    Decision Date
    August 10, 1987
    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

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (KOD), ordered by most recent decision date.

    Rubber Utility Catheter

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    Wellead Ureteral Catheter

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    allFlex Ureteral Catheters, Krait Ureteral Catheters

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    Urinary Catheter 12 Fr, Urinary Catheter 16 Fr

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    Rusch FloCath Quick 18 Fr. Coudé Hydrophilic Intermittent Catheter

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    UroGen Ureteral Catheter

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology
    View all

    Other Clearances by American Pharmaseal Div. Ahsc

    K Number Device Name
    K874022 PHARMASEAL WOUND IRRIGATION DEVICE
    K874517 PHARMASEAL RUBBER URETHRAL CATHETER
    K874045 PHARMASEAL ENDOSCOPY PREP KIT UPPER AND LOWER
    K873359 AIRLIFE VOLUME VENTI. CIRCUIT W/CLEAR CAP EX VALVE
    K872228 PHARMASEAL ALTERNATING PRESSURE PAD SYSTEM
    K872917 JINOTTI SUCTION/OXYGEN INSUFFLATION CATHETER
    K871770 AMERICAN PHARMASEAL WOUND DRESSING
    K870387 EUROMEDICAL, ENDOSOFT ENDOTRACHEAL TUBE
    K870977 PHARMASEAL T TYPE THERMOCOUPLE 100% CATH./PROBE
    K870941 PHARMASEAL WOUND CARE DRESSING PAD
    Search all 64 clearances from American Pharmaseal Div. Ahsc →