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

    KENDALL CURITY CATHETER PLUG WITH PROTECTIVE CAP

    K Number: K951488 · Decision Apr 25, 1995
    View on FDA
    Classifications
    1
    FEI Numbers
    38
    Registration Numbers
    38
    Same Product Code
    63
    Applicant Total
    63
    Review Days
    25

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    Basic Information

    Device Name
    KENDALL CURITY CATHETER PLUG WITH PROTECTIVE CAP
    K Number
    K951488
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5130
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    The Kendal Co.
    Date Received
    March 31, 1995
    Decision Date
    April 25, 1995
    Product Code
    KNY
    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
    KNY Accessories, Catheter, G-U

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    Other Clearances by The Kendal Co.

    K Number Device Name
    K000087 MARHUKAR TRIPLE LUMEN CATHETER, MODEL 12 FR
    K990500 KENDALL ULTRAMER COUDE FOLEY CATHETER, MODEL 1416C, KENDALL CURITY COUDE FOLEY CATHETER TRAY, MODEL 6946C
    K991758 MONOJECT INSULIN SYRINGE
    K970969 KENDALL CURITY SUPRAPUBIC CATHETER TRAY, KIT, & REPLACEMENT SET
    K942664 KENDALL MODEL 6325 SCD SEQUEL COMPRESSION SYSTEM
    K942774 POLYSKIN(R) M.R. MOIST RESPONSIVE TRANSPARENT DRESSING
    K892434 KENDALL CURITY OXYGEN MASK
    K892438 KENDALL CURITY INTRAVASCULAR CUT DOWN TUBES
    K892440 KENDALL CURITY EXTENSION TUBES
    K892436 KENDALL CURITY IRRIGATION SYRINGE
    Search all 63 clearances from The Kendal Co. →