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

    BETTER-BLADDER (BB)

    K Number: K964337 · Decision May 23, 1997
    View on FDA
    Classifications
    1
    FEI Numbers
    21
    Registration Numbers
    21
    Same Product Code
    34
    Applicant Total
    9
    Review Days
    204

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    Basic Information

    Device Name
    BETTER-BLADDER (BB)
    K Number
    K964337
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5820
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Circulatory Technology, Inc.
    Date Received
    October 31, 1996
    Decision Date
    May 23, 1997
    Product Code
    FIB
    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
    FIB Protector, Transducer, Dialysis

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    Other Clearances by Circulatory Technology, Inc.

    K Number Device Name
    K140321 INITARY BETTER BLADDER-PEDIATRIC
    K012942 THE V BAG, CATALOG NUMBER VB1800; VAC-BOX FOR VACUUM ASSISTED VENOUS DRAINAGE, CATALOG NUMBER VACBOX1500
    K001822 THE V-BAG
    K981284 BETTER-BLADDER (BB)
    K964205 BETTER-TUBING
    K961594 BETTER-VENTER
    K941492 PRESSURE RELIEF VALVE
    K942933 PRESSURE INFUSION CUFF